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

Catalog Number 300613

Device Problems Leak/Splash (1354); Malposition of Device (2616)

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

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(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 black seal is not correctly in place resulting in leakage.

Manufacturer Narrative

H.6.Investigation summary: it has been received 1 used sample of 20ls lot 1808275 without blister for investigation.Upon visual inspection of the sample received, it can be observed the stopper is wrongly assembled to the plunger.No damage or molding defect can be observed in the plunger rod that could have caused this defect.Dhr of lot 1808275 has been reviewed not finding any annotation or deviation regarding the alleged defect.In assembly station of this manufacturing line there is a photo-cell to detect missing stopper and stopper wrong assembled.A failure in detection caused this syringe continues to the following manufacturing processes.According to inspection plan procedure jg-500, 200 units are inspected every 2 pallets by quality control team.In addition, final products in this manufacturing line, for this reference and lot size are sampled by operator and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures (jg-301, jg-302, jg-303 and jg-304): 1.Visual inspection: molding: 2 injections per shift.Printing: 24 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Assembly: 24 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Primary packaging: 1 advance-step (without product) per hour, after any intervention in the equipment, and once at the beginning of the shift.Secondary packaging: 1 shelf-package per pallet.2.Functional inspection: printing: once in pallet#1, and once in pallet#22.Assembly: once in pallet#1, and once in pallet#22.Primary packaging: once in pallet#1, and once in pallet#22.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 misalignment of plunger-stopper-barrel in the assembly station.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 based on no quality notification was opened during manufacturing process of this lot.

Event Description

It was reported that during use of the bd plastipak¿ syringe the black seal is not correctly in place resulting in leakage.

• Brand Name: BD PLASTIPAK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8261293
• MDR Text Key: 133851410
• Report Number: 3003152976-2019-00002
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: 30382903006138
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• 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: 300613
• Device Lot Number: 1808275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other