MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 27 G X 3.5. IN. BD¿ WHITACRE PENCIL POINT SPINAL NEEDLE; ANESTHESIA SPINAL NEEDLE

Catalog Number 405075

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a 27 g x 3.5.In.Bd¿ whitacre pencil point spinal needle broke off in the patient during use.Medical intervention required.

Manufacturer Narrative

Results: bd did not receive any samples or photos from the customer in support of this complaint.Two retained samples have been evaluated.No defects which may produce the claimed defect were found.The manufacturing records were reviewed for the incident lot and no discrepancies or non-conformance were reported that could have contributed to the reported condition.(b)(4) investigation: needle broken during use.Customer stated that spinal needle has broken at removal into patient¿s back leaving a part of cannula into it.Molding and assembly process are performed in bd (b)(4).Spinal needles arrived from (b)(4) (cannula and stylet already assembled) and are manually assembled with the introductor in (b)(4) (according to (b)(4) current version).This operation is performed with extremely care as the introductory hub is not attached to the cannula.During this process, the operator noticed possible defects in the spinal needles.Faulty spinal needles are discarded.Packaging process also takes place in (b)(4).Spinal needles are manually placed in the packing machine.Once packed in the blister, they are introduced in the unit case.In process inspection is performed according to (b)(4) (current version): packing: one strip of product per 4 bags (4,000 needles aprox.) is checked to verify: correct product packaging, product free of damages and dirt, etc.Packaging: during the packaging process of the product, 100% visual inspection of the product is performed by the operator.On the other hand, unit case inspection (25 spinal needles) is performed for each two rows and at the end of the pallet/lot according.In case of faulty part, the operator: removes the defected product.In case of more than 2 defects/ 50 samples, the packing operator has to be informed.If the defect persists, the leader team or process inspector has to be advised.The three (3) juncos lots # 6081840, 6098692 and 6098696 were assembled in tic machine # 5 under sub-assembly part number # 700006011.Following is the summary of the device history records review for each lot: lot 6081840: sub-assembly lot# 6070949 was manufactured on 18-mar-2016, 21-mar-2016 and 22-mar-2016 as per production order # (b)(6).Two breakdowns, ref.# (b)(4) were issued to address clogged cannula on 19-mar-2016 and 22-mar-2016.Pilots and ¿platinas¿ were replaced to correct the condition.No product was identified as impacted due to this correction.Final inspection as per (b)(4) was performed on 22-mar-2016 with satisfactory results and product was released for subsequent packing operation on 23-mar-2016.Product was packed on 23-mar-2016 under lot # 6081840 and production order # (b)(6).A total of (b)(4) units were released for shipping on 29-mar-2016.The lot expiration date is 31-mar-2021.Lot 6098692: sub-assembly lot# 6097663 was manufactured on 08 apr 16, 09 apr 16, 10 apr 16, 11apr16 and 12apr16 as per production order # (b)(6).One breakdown, ref.# (b)(4) was issued to address clogged cannula on station no.3 on 12 apr 16.The cooping was replaced to correct the condition and no product was identified as impacted due to this condition.Final inspection as per (b)(4) was performed on 12 apr 16 with satisfactory results and product was released for subsequent packing operation on 13apr16.Product was packed on 15 apr 16 under lot # 6098692 and production order # (b)(6).A total of (b)(64 units were released for shipping on 30apr16.The lot expiration date is 30apr21.Lot 6098696: sub-assembly lot 6098536 was manufactured on 12apr16, 13apr16 and 14apr16 as per production order # (b)(6).One breakdown, ref.# (b)(4) issued to address flare issues on cavity no.4.Flare was adjusted to correct the condition according (b)(4).Affected travel ticket ref.# (b)(4) units was re-inspected accordingly.Final inspection as per (b)(4) was performed on 15apr16 with satisfactory results and product was released for subsequent packing operation on 25apr16.Product was packed on 25apr16 under lot # 6098696 and production order # (b)(6).A total of 63,200 units were released for shipping on 26apr16.The lot expiration date is 30apr21.As per (b)(4) all in process inspections including visuals, dimensional and functional performed at the shift beginning and every 4 hours passed with satisfactory results.These lots were packed as bulk non-sterile.Conclusion: bd was not able to confirm that the customer¿s indicated failure mode is associated with the manufacturing processes.The root cause of the defect couldn't be established.

• Brand Name: 27 G X 3.5. IN. BD¿ WHITACRE PENCIL POINT SPINAL NEEDLE
• Type of Device: ANESTHESIA SPINAL NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6865601
• MDR Text Key: 86155517
• Report Number: 3003152976-2017-00035
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 405075
• Device Lot Number: 1702014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 08/22/2017
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention