MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK SYRINGE; PISTON SYRINGE

Catalog Number 990173

Device Problems Break (1069); Failure to Deliver (2338)

Patient Problem Pain (1994)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

It was reported that the bd plastipak syringe plunger movement was difficult and the plunger rod was broken.The following information was provided by the initial reporter: syringe offering resistance to pull the plunger.It is causing pain when handling professionals, in addition to increasing the consumption of the product; part of the plunger that is pushed by the finger breaks during the use of the syringe.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for additional lot number is as follows: medical device lot #: 1228464.Medical device expiration date: 31-aug-2026.Device manufacture date: 16-aug-2021.Medical device lot #: unknown (customer reported 132398, but this lot# number is missing a digit).Medical device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that the bd plastipak syringe plunger movement was difficult and the plunger rod was broken.The following information was provided by the initial reporter: syringe offering resistance to pull the plunger.It is causing pain when handling professionals, in addition to increasing the consumption of the product; part of the plunger that is pushed by the finger breaks during the use of the syringe.

Manufacturer Narrative

H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD PLASTIPAK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16428867
• MDR Text Key: 310437446
• Report Number: 3003916417-2023-00043
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/24/2023

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: 990173
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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