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

Catalog Number 300629

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Laceration(s) (1946)

Event Date 10/11/2018

Event Type  malfunction  

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.

Event Description

It was reported with the use of the bd plastipak¿ syringe there was an issue with syringe splitting into pieces in the hand of the physician giving a cut in his hand.There was no report of medical intervention.

Manufacturer Narrative

One opened sample and five sealed samples were received for evaluation by our quality engineer.Upon visual inspection of the used sample, the plunger rod was observed broken.Visual inspection did not reveal any damages or molding defects in the remaining unopened samples.The unopened samples were functionally tested and no signs of breakage were observed to the plungers.A device history record review for lot number 1806255 revealed one annotation during the production process that may have contributed to this incident.During the assembly process, a failure was detected in the plunger assembly station.Once the failure was detected, the mechanical team repaired the failure and all defective product should have been rejected.It is possible that the failure within the plunger assembly station resulted in this product incident.The manufacturing facility have been made aware of this incident.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported with the use of the bd plastipak syringe there was an issue with syringe splitting into pieces in the hand of the physician giving a cut in his hand.There was no report of medical intervention.

• Brand Name: BD PLASTIPAK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8061679
• MDR Text Key: 127882535
• Report Number: 3003152976-2018-00485
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 12/06/2018

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: 05/31/2023
• Device Catalogue Number: 300629
• Device Lot Number: 1806255
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 10/26/2018
• Supplement Dates FDA Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other