MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CORRECTINJECT SPINAL KIT; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number 910/400/380

Device Problem Break (1069)

Patient Problem Extubate (2402)

Event Date 05/14/2015

Event Type  Injury  

Event Description

User facility reported that the tip of the pulsator syringe broke off inside the 3-way stopcock attached to a transducer.The facility reported that the breakage occurred while the nurse was taking a blood sample from the 3-way stopcock.The nurse tried to remove the syringe tip from the 3-way stopcock, but was unsuccessful, therefore; the whole transducer kit needed to be replaced.There were no adverse effects to pt.

Manufacturer Narrative

Smiths medical has rec'd the sample device.A full eval is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a f/u report detailing the results of the eval once it is completed.

Manufacturer Narrative

Device evaluation: manufacturing review for reported lot showed no deviations or abnormalities related to the reported issue.Two used transducers (unknown manufacturer) were returned with pulsator luer tips broken off within the luer lock fittings of the stopcocks.One hundred eighty-three unused samples were returned for evaluation.Visual inspection determined that 20 of these samples had visual deformities at the luer tapers.All of the returned samples were given functional testing.Of the 183 returned unused samples, all passed testing except for two of the samples.For the two returned unused samples that did not pass; the device luers broke off inside of mating part (stopcocks).The reported issue (breakage of the luer on the syringe) could be confirmed for 2 of the returned unused sample.A safety corrective action request has been sent to the supplier.

Manufacturer Narrative

The investigation, performed by the barrel component supplier, could not confirm the deformities on the barrel were caused during molding process.Additional investigation of smiths manufacturing process confirmed that the syringe assembly machine is capable of creating deformities, observed on the returned product.To ensure the product quality the machine is routinely adjusted during the production by a technician.Machine maintenance log review for the period of product assembly revealed records relevant to cap station, resulted in missing caps, cap installation and alignment problems.The barrels, not successfully capped by the machine, may be visually inspected, manually capped and the caps snapped tight on the barrel luer by using an additional fixture.The deformed luers could potentially not be noticed at the time by the operator during cap installation.A corrective and preventative action was issued to engineering to further investigate and correct the syringe assembly machine issues that resulted in the barrel luer deformities.

• Brand Name: PORTEX CORRECTINJECT SPINAL KIT
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 10 bowman dr; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4847717
• MDR Text Key: 5873002
• Report Number: 2183502-2015-00410
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 910/400/380
• Device Lot Number: 2877406
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2015
• Distributor Facility Aware Date: 05/14/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1