MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD 10ML SYRINGE LUER-LOK TIP BULK CONVENIENCE PAK; PISTON SYRINGE

Catalog Number 309604

Device Problem Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 84 bd 10ml syringe luer-lok¿ tips bulk convenience pak experienced discolored blister packs/trays (primary packaging).The following information was provided by the initial reporter: during inspection, yellow dirt (fm) on packages were found.

Event Description

It was reported that 84 bd 10ml syringe luer-lok¿ tips bulk convenience pak experienced discolored blister packs/trays (primary packaging).The following information was provided by the initial reporter: during inspection, yellow dirt (fm) on packages were found.

Manufacturer Narrative

The following fields were corrected: d10: device available for eval: no.D10: returned to manufacturer on: na.H6: investigation summary: pictures received for investigation, four 10 ml syringes with yellow dirt are observed.Several photographs are received in which it is possible to observe yellow spots in several of the corners of the blister paper, it is important to mention that in these the yellow coloration is not perceptible inside the primary packaging and / or on the surface of the product.The review of the investigation reports of non-conforming raw material reported by productive areas was carried out, finding no reports of events to the supplier due to contamination, however, there is a photograph in which a reel can be observed completely sealed, with a stain like that observed in the photographs sent by the customer.It is important to mention that, during the manufacturing, packaging and / or internal distribution process of the product, no failure modes were found that could generate the yellow stain, on the other hand, as there are no physical samples, it is not possible to carry out a more in-depth analysis.During the documentary review of the batch 9339588 no quality events records in the product manufacture were found, the batch was inspected and later released accordance with the valid work instruction.H3 other text : see h10.

• Brand Name: BD 10ML SYRINGE LUER-LOK TIP BULK CONVENIENCE PAK
• 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: 11336160
• MDR Text Key: 261316953
• Report Number: 9614033-2021-00019
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

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: 309604
• Device Lot Number: 9339588
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1