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

Catalog Number 300613

Device Problem Packaging Problem (3007)

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

Event Date 12/04/2018

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 package damaged and open from one side full of black dirt.

Event Description

It was reported with the use of the bd plastipak¿ syringe there was an issue with package damaged and open from one side full of black dirt.There were two occurrences of this incident reported within the month.Discovered before use.

Manufacturer Narrative

Correction: describe event or problem: it was reported with the use of the bd plastipak¿ syringe there was an issue with package damaged and open from one side full of black dirt.There were two occurrences of this incident reported within the month.Discovered before use.Investigation summary: two samples belonging to lot number 1809272 were received for evaluation by our quality engineer.Through visual inspection of the samples, the packages were observed open on one side due to an extra piece of foreign paper within the seal.A device history record review did not reveal any documented quality issues during the production of lot number 1809272 that could have contributed to this incident.Investigation conclusion: during the primary packaging process, film and paper are guided along a chain in the packaging machine.Once the blister packaging is sealed, longitudinal and transversal cutters cut the extra pieces of film and paper and they are rejected to scrap by a vacuum system.A failure in the vacuum system resulted in improper rejection of the extra paper and film pieces, which caused them to be sealed within the following blister packages.The black foreign matter is grease from the manufacturing chain where the film and paper are guided.Rationale: manufacturing personnel have been made aware of this incident.Based on the preventive measures in place and the current inspection plan, we believe this is an isolated incident with an unlikely reoccurrence.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: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8199671
• MDR Text Key: 131594973
• Report Number: 3003152976-2018-00547
• 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: 01/09/2019

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: 08/31/2023
• Device Catalogue Number: 300613
• Device Lot Number: 1809272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other