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

Catalog Number 300629

Device Problem Obstruction of Flow (2423)

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

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd plastipak¿ syringe pumps triggered downstream occlusion alarms during infusion and stopped.No serious injury or medical intervention was reported.

Manufacturer Narrative

H.6.Investigation: a total of eight samples belonging to lot number 1808237 were received for evaluation by our quality engineer.Three photos and two videos were also provided and reviewed by our quality team.Upon visual inspection of the samples, no damages or molding defects were observed in the syringes.A device history record review did not reveal any quality issues during the production of this lot number that could have contributed to the reported incident.During the manufacturing process, samples for each lot produced are testing for silicone content, break-out force, and sustaining force to ensure the product is within specifications.Based on the investigation results, an exact cause for the reported incident could not be determined.

Event Description

It was reported that bd plastipak¿ syringe pumps triggered downstream occlusion alarms during infusion and stopped.No serious injury or medical intervention was reported.

• 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: 8362538
• MDR Text Key: 137430668
• Report Number: 3003152976-2019-00174
• 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: 03/21/2019

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: 07/31/2023
• Device Catalogue Number: 300629
• Device Lot Number: 1808237
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other