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

Catalog Number 300629

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2023

Event Type  malfunction  

Event Description

It was reported that the bd plastipak¿ syringes packaging is not properly sealed.The following was received by the initial reporter: verbatim: product appears to either be not properly sealed or perforations have been incorrectly aligned during manufacture so the individual packs are open already, affecting sterility etc.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 28-jul-2023.H6: investigation summary: one sample and two photos were provided to our quality team for investigation.Upon visual inspection, it is noted the sealing cord is not present on one of the side of the packaging.A device history review was performed for reported lot 2208104, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.We have reviewed our production and inspection records and have established that all production and quality processes were carried out without issue.While we cannot identify a direct issue, it was determined this incident likely occurred during the packaging process as a result of the product being in the incorrect position when the blades cut the packaging.

Event Description

It was reported that the bd plastipak¿ syringes packaging is not properly sealed.The following was received by the initial reporter: verbatim: product appears to either be not properly sealed or perforations have been incorrectly aligned during manufacture so the individual packs are open already, affecting sterility etc.

• Brand Name: BD PLASTIPAK¿ SYRINGES
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17447357
• MDR Text Key: 320304948
• Report Number: 3003152976-2023-00312
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300629
• Device Lot Number: 2208104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1