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

Catalog Number 301229

Device Problem Material Deformation (2976)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd plastipak¿ syringes the tip of the syringe was deformed.This is report 1 of 2.There was no report of patient impact.The following information was provided by the initial reporter, translated from italian to english: the customer states that the syringe tip is deformed and has 'ink' in it.When did the incident occur? before use.The comment from bd rep: it appears that the rubber has degraded.We bring to the attention of the s.V.That in refilling the various trolleys in the various rooms, we have noticed that some 30 cc luer-lock syringes show deformation on the tip and presence of printing ink.

Event Description

It was reported while using bd plastipak¿ syringes the tip of the syringe was deformed.This is report 1 of 2.There was no report of patient impact.The following information was provided by the initial reporter, translated from italian to english: the customer states that the syringe tip is deformed and has 'ink' in it.When did the incident occur? before use the comment from bd rep: it appears that the rubber has degraded.We bring to the attention of the s.V.That in refilling the various trolleys in the various rooms, we have noticed that some 30 cc luer-lock syringes show deformation on the tip and presence of printing ink.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 03-jul-2023.H6: investigation summary two samples and photos received by our quality team for investigation.Upon visual evaluation, it can be seen there is ink in the tip of both syringes.One of them has more ink over the barrel, the second syringe has a small spot.No damage on the luer can be observed.No other defects or issues identified.A device history review was performed for the reported lot 2010080, maintenance record was identified during the manufacturing process that could have contributed to this issue.Based on the quality team¿s investigation, the root cause of the incident is associated with marking machine adjustments.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.

• 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.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16756766
• MDR Text Key: 313638188
• Report Number: 3003152976-2023-00140
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903012299
• UDI-Public: (01)00382903012299
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

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: 301229
• Device Lot Number: 2206006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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