MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 10ML LL

Catalog Number 305959

Device Problem Packaging Problem (3007)

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

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

Date received by manufacturer: bd was initially made aware of this complaint on 2021-05-03.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 2021-06-21 that changed the reportability determination.Based on the additional information received, this complaint is now considered to be an mdr reportable incident.Six samples were provided to our quality engineer for investigation.Through visual inspection it was observed that top web of the package has a red tape and two paper backing are overlapped, the red tape preventing the proper sealing of the blister package.A device history record review did not reveal any documented quality issues during the production of lot number 2010044 that could have contributed to this incident.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.This adhesive tape is used during the packaging process when the paper roll is replaced, adhering the end of the roll to the new roll.There is a detector in the packaging machine to identify this portion of material and automatically reject to scrap.Investigation conclusion: complaints for this device and defect will continue to be monitored by our quality team for signs of emerging trends.Root cause description: while we could not identify a direct issue, it was determined this incident occurred due to the replacement of the paper coil.Manufacturing personnel have been made aware of the experience to increase awareness of this issue.Rationale: no corrective action is required at this time.

Event Description

It was reported that syringe 10ml ll package was damaged.This occurred on 6 occasions.The following information was provided by the initial reporter: the medical device has malfunctioned, rendering it unusable.Double packaging of the syringes with red tape.6 syringes in this batch have this double packaging.

• Brand Name: SYRINGE 10ML LL
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12051582
• MDR Text Key: 265846430
• Report Number: 3003152976-2021-00338
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305959
• Device Lot Number: 2010044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2020
• 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