MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 326785

Device Problem Contamination (1120)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 the bd ultra-fine¿ insulin syringe had foreign matter.Report 1 of 2.The following information was provided by the initial reporter, translated from spanish to english: once again, i am writing to highlight the comment that i had already made you know in fact about the drops of liquid that the new syringes already have when the package is opened.I have already thrown away several syringes due to insecurity about this liquid.Why do they come with that liquid if they are supposed to be new? and besides, the probe of one of the syringes was clogged.

Manufacturer Narrative

H.6.Investigation summary: no physical samples were received however the investigation was performed based on the photo(s) provided.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Embecta was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situation analysis (sa) is required at this time.

Event Description

It was reported that the bd ultra-fine¿ insulin syringe had foreign matter.Report 1 of 2.The following information was provided by the initial reporter, translated from spanish to english: once again, i am writing to highlight the comment that i had already made you know in fact about the drops of liquid that the new syringes already have when the package is opened.I have already thrown away several syringes due to insecurity about this liquid.Why do they come with that liquid if they are supposed to be new? and besides, the probe of one of the syringes was clogged.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18838143
• MDR Text Key: 337782208
• Report Number: 9614033-2024-00021
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326785
• Device Lot Number: 3072789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• 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