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

Catalog Number 300865

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 11/17/2018

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 that during use of the bd plastipak¿ syringe the rubber stopper produces greater resistance when spreading drug products.

Event Description

It was reported that during use of the bd plastipak¿ syringe the rubber stopper produces greater resistance when spreading drug products.

Manufacturer Narrative

Investigation summary: a device history record review was performed for the provided lot number (1806225).The review did not reveal any quality issues during the production process that could have contributed to the reported incident.As neither a physical sample nor a picture sample was available for return, ten retained samples of the same lot number were obtained for further investigation.Investigation conclusion: through visual inspection of the retained samples, no damages or defects were observed.Silicone content testing, break out testing, and sustaining force testing were completed on the retained samples.All of the retained samples performed per specifications.Root cause description: as a manufacturing related defect could not be identified, a cause for this incident could not be determined.Rationale: complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.

• 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: 8190721
• MDR Text Key: 131334909
• Report Number: 3003152976-2018-00572
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 300865
• Device Lot Number: 1806225
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other