MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 20ML LL S/C 50; PISTON SYRINGE

Catalog Number 303310

Device Problem Packaging Problem (3007)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0015659, medical device expiration date: 2025-01-31, device manufacture date: (b)(6) 2020.Medical device lot #: 0098739, medical device expiration date: 2025-04-30, device manufacture date: (b)(6) 2020.Medical device lot #: 0290115, medical device expiration date: 2025-10-31, device manufacture date: (b)(6) 2020.The customer's address is unknown.New jersey (nj), usa has been used as a default.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 that syringe 20ml ll s/c 50 packaging ripped and contaminated the sterile field.The following information was provided by the initial reporter: material no.: 303310, batch no.: 0015659, 0098739, 0161042.It was reported that packaging splits and rips when opening, contaminating the sterile field.

Event Description

It was reported that syringe 20ml ll s/c 50 packaging ripped and contaminated the sterile field.The following information was provided by the initial reporter: material no.: 303310 batch no.: 0015659, 0098739, 0161042.It was reported that packaging splits and rips when opening, contaminating the sterile field.

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.H3 other text : see h10.

• Brand Name: SYRINGE 20ML LL S/C 50
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 11822296
• MDR Text Key: 251437267
• Report Number: 9614033-2021-00056
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303310
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1