MAUDE Adverse Event Report: BD CARIBE LTD. BD PERISAFE¿ EPIDURAL MINI-KIT; EPIDURAL KIT

Catalog Number 400273

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported during use of the bd perisafe¿ epidural mini-kit ¿when the product was introduced to the patient it was with difficulty, pressure is felt.When it was removed a piece of the catheter was missing.Tac is performed, but the tip of this was not found.The patient is stable, the family was notified of what happened and will be kept under observation.¿.

Manufacturer Narrative

Investigation results: one picture was included in the complaint record.Additional pictures were provided to bd juncos by email of the entire catheter sample.The sample is located in bd chile facility.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of catheter broke with lot #6197591 regarding item #400273.This investigation consisted in the evaluation of the incoming inspection records of the catheter component (material no.4829500aau catheter 20ga c/e 2039-2) which was reported broken by the customer.In addition, a review of the needle assembly and packaging process will be conducted for any indication of situations that could contribute to the customer reported failure of catheter broke.The perisafe technical file (b)(4) was used as reference document on this investigation.Background: the production of kits is essentially a packaging operation which consists of placing components into the preformed blister, placing a lid onto the blister, sealing the package, and finally dies cutting the package away from the trim.Finished assemblies are inspected as appropriate.According to product specification, sp1848 rev.03, the perisafe¿ epidural anesthesia mini-kit provide the basic components necessary to perform the epidural anesthesia procedure.In this procedure the epidural needle is positioned first and an epidural catheter is positioned to provide continuous epidural anesthesia.The device comprises the following components: fixed wing epidural needle / material no.5002059aau.Nylon epidural catheter pack / material no.4829500aau c.Epidural filter assembly / material no.5002056aau.Lor syringe / material no.405199.Catheter connector / material no.4882200aau.Preformed blister / material no.3040700aa.Tyvek lid / material no.8605980.From these components, the epidural catheter pack as per product specification sp1835 rev.05, is intended to administer continuous epidural anesthesia by following the needle into the epidural space and connecting directly to a catheter connector that can be attached to a standard luer syringe.The catheter pack is a bulk, non-sterile component of ssu anesthesia sets, kits and trays.The device comprised of the following components: catheter, thread assist, polybag (printed with the appropriate identification).All these components listed in sp1848 and sp1835 respectively, are received from different bd juncos approved suppliers (internal/external) and are subjected to the applicable receiving inspection at the incoming area.Then, components are dispatched to the alloyd packaging line according to the catalog production schedule.The only component from this kit that is assembled in bd juncos manufacturing process is the fixed wing epidural needle.The remaining components are only processed in the packaging area where the perisafe kit is prepared.Incoming inspection: the component involved in the complaint is the catheter 4829500aau which according to the batch status report from sap system, used the lots 73f1600561, 73f1600560, 73g1600184 and 73b1500414.This component is supplied by tfx medical, jaffrey, nh (final mfg: tecate, mexico).The material type is a pebax 6333 tubing w/(1) tungsten 10% stripe and polypropylene thread assistance.This catheter is received individually packaged in printed polybag with the appropriate identification.The material is purchase and inspected as per the requirements set forth in buy specification, sb854-04.The incoming inspection included visual, dimensional and functional testing.Following is the inspection summary results for the length, elongation/strength and visual test: overall length specification 36in tolerance +.50 / -.00 (min.36.0 / max.36.50) elongation specification 250% minimum tensile strength 20ga = 3.6lbs minimum.Lot 73b1500414 inspected on 09mar2015 ¿ length 32 samples all within length specification; elongation 20 samples all within specification (fluctuates between 563.803% up to 815.845%) with peak load (strength) from 5.206lbf to 7.007lbf.Lot 73f1600560 inspected on 15jul2016 ¿ length 32 samples all within length specification; elongation 20 samples all within specification (fluctuates between 718.263% up to 1044.7375%) with peak load (strength) from 4.869lbf to 7.145lbf.Lot 73f1600561 inspected on 18jul2016 ¿ length 32 samples all within length specification; elongation 20 samples all within specification (fluctuates between 759.885% up to 1041.502%) with peak load (strength) from 4.999lbf to 6.463lbf.Lot 73g1600184 inspected on 28jul2016 ¿ length 32 samples all within length specification; elongation 20 samples all within specification (fluctuates between 611.362% up to 1048.317%) with peak load (strength) from 5.039lbf to 6.493lbf.These four (4) lots were visually inspected including the depth marking correctly and clearly printed, catheter tip condition among other visual characteristics.On each lot, 200 samples were inspected (total lots samples = 800) and no non-conformance or discrepancies were reported.According to the incoming inspection, the catheter lots 73f1600561, 73f1600560, 73g1600184 and 73b1500414 meets the bd specification requirements.No non-conformances scar or qn¿s were reported.Refer to the attachments on the investigation document attached.Needle assembly process: the needle 18ga x 3 ½in fixed wing was assembled under part number 5002059aau in the auburg insert molding machine from (b)(6) 2016 under production order# (b)(4) lot 6174802.In process inspections were performed as per (b)(4) during manufacturing runs and final quality inspection as per (b)(4) on 20jul16.The needle lot was released for packing 22jul16.No non-conformances reported from the needle assembly process.Machine conditions no breakdowns were reported on auburg insert molded and alloyd packing machines during the period when the lot was processed.Preventive maintenance on the auburg and alloyd machines were conducted as per schedule.Review of instrument calibrations identified in quality inspection records was conducted and they were calibrated within their calibration due dates.Perisafe packaging process: on the packaging area the catheter is manually placed in the tray to be sealed in the alloyd packaging machine.No indications on the mini kit process fmea, rm692 rev.1 of failures associated with catheter broken from the packaging process.The current controls in the pfmea for other failures in the packaging process such as missing components or incorrect components are the 100% visual inspection at next step operation and incoming inspection.The perisafe lot 6197591 was released in quarantine for sterilization process on 29jul16.A total of (b)(4) units were released from sterilization on 30aug16.The lot expiration date is 31jul2021.Pictures evaluation: on (b)(6) 2018 additional pictures of the sample and length measurement were requested to bd chile in order to perform the sample evaluation and to compare with component (4829500aau) buy specification requirements.According to bd chile, the sample measured 32.2 inches (82cm) which is an approximately of 3.8 inches less than the specification requirements of 36in (+.50).The catheter has 22 printed marks distributed from tip to an approximate 12 inches distance length.When compared the picture of the complaint sample with a good sample from bd juncos inventory it was confirmed the condition of broken catheter from the tip area up to 4in approximate.Summary: based on the evaluation of the incoming inspection records for catheter 4829500aau lots 73f1600561, 73f1600560, 73g1600184 and 73b1500414, no non-conformances or discrepancies were reported.The required inspections according bd product specifications sp1848 and sp1835 meets the acceptance criteria.Bd juncos was able to confirm the customer indicated failure of broken catheter with the picture provided by bd chile.The root cause cannot be associated with the manufacturing process since no indications from the manufacturing records review of situations that could contribute to the customer reported failure of broken catheter.The catheter functional, dimensional and visual inspections were found in accordance with bd specifications.

• Brand Name: BD PERISAFE¿ EPIDURAL MINI-KIT
• Type of Device: EPIDURAL KIT
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7375394
• MDR Text Key: 103650450
• Report Number: 2618282-2018-00009
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904002732
• UDI-Public: 00382904002732
• Combination Product (y/n): N
• PMA/PMN Number: K953790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 400273
• Device Lot Number: 6197591
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention