MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE PLASTIPAK 1ML INSULIN S/SU; PISTON SYRINGE

Catalog Number 990256

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

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 that 2 bd syringe plastipak 1ml insulin s/su had product damage and leakage issues.The following information was provided by the initial reporter : it was reported that during an intravitreal injection procedure in a patient the medication was lost because the syringe was damaged on the side with a cracked barrel resulting in leakage.

Manufacturer Narrative

H.6.Investigation: the analysis of the batch history (dhr), maintenance records and quality notifications were verified.Through the analysis of the video sent by the customer, it is possible to observe leakage through the syringe body due to the barrel being damaged.The root cause may be related to a jam after the product assembly step.

Event Description

It was reported that 2 bd syringe plastipak 1ml insulin s/su had product damage and leakage issues.The following information was provided by the initial reporter: it was reported that during an intravitreal injection procedure in a patient the medication was lost because the syringe was damaged on the side with a cracked barrel resulting in leakage.

• Brand Name: BD SYRINGE PLASTIPAK 1ML INSULIN S/SU
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12537704
• MDR Text Key: 273551784
• Report Number: 3003916417-2021-00305
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K024112
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 990256
• Device Lot Number: 1022225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2021
• 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