MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOCK SYRINGE

Catalog Number 301229

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2018

Event Type  malfunction  

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 plastipak¿ luer-lock syringe there was an issue with sterility.The customer states ¿the product comes in strips of 6 syringes.The end of the strip (last syringe) is not sealed hence causing a breach in sterility.Ten strips within each box not sealed, twenty strips in total.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Thirteen blisters of 30ml ll, lot 1710209 and one picture were received for investigation.Upon visual inspection of the samples received and the picture, twelve blisters are not sealed along one lateral side, which verifies the poor integrity of the packaging.These twelve blisters are all from cavity 6 and it was also observed that there is double paper layer in the sealing cord.The other blister received is from cavity 5 and no sealing defect can be observed in it, it is correctly sealed.A device history record review of lot 1710209 found no non-conformances associated with this issue during production of this batch.Based upon the quality team's investigation, the root cause of this incident is related to a failure of paper position during packaging process.Although no issues were identified and manufacturing record stablished that all production and quality processes were carried out normally, we can confirm that the root cause of the non-conformance is related with a failure of paper position during packaging process.Based on all the preventive measures and our stringent in ¿process inspection plan, we are certain that this should be an isolated issue and any recurrence is really unlikely bases on no quality notification was opened during manufacturing process of the alleged lot.A corrective action has been initiated to install a detector for paper movement in packaging machine.Based on severity and occurrence no formal capa is required according to internal procedure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PLASTIPAK¿ LUER-LOCK SYRINGE
• Type of Device: SYRINGE
• 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: 7434277
• MDR Text Key: 105898682
• Report Number: 3003152976-2018-00149
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 301229
• Device Lot Number: 1710209
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2017
• 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): Other