MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE 1ML LS SP120

Catalog Number 303172

Device Problem Fungus in Device Environment (2316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

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 the bd syringe 1ml ls sp120 had foreign matter inside the packaging.The following information was provided by the initial reporter: verbatim: mediq received a complaint about syringes where the pouch shows some kind of debris.It looks like fungi but can also be oil or ink from a machine.

Event Description

It was reported that the bd syringe 1ml ls sp120 had foreign matter inside the packaging the following information was provided by the initial reporter: verbatim: mediq received a complaint about syringes where the pouch shows some kind of debris.It looks like fungi but can also be oil or ink from a machine.

Manufacturer Narrative

H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for the reported lot 1911005, no deviations or non-conformance's were identified during the manufacturing process that could have contributed to this issue.Ten retained samples of lot 1911005 were used for additional evaluation.The products were visually inspected, no foreign matter was observed on the product or inside the blister packaging.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we are not able to determine a root cause at this time.

• Brand Name: BD SYRINGE 1ML LS SP120
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 9745582
• MDR Text Key: 193099259
• Report Number: 3002682307-2020-00061
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303172
• Device Lot Number: 1911005
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other