MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML LS EMERALD

Catalog Number 302986

Device Problem Packaging Problem (3007)

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

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and the(b)(4) fda registration number has been used for the manufacture report number.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 3ml ls emerald had an affected seal.The following information was provided by the initial reporter: we get the comment from our op service that the syringes have an affected seal.It is certainly not condensed.We would like to check whether there is a sterility problem with these syringes.

Event Description

It was reported that syringe 3ml ls emerald had an affected seal.The following information was provided by the initial reporter: we get the comment from our op service that the syringes have an affected seal.It is certainly not condensed.We would like to check whether there is a sterility problem with these syringes.

Manufacturer Narrative

H6: investigation summary: a photo was received by bd for evaluation.A quality engineer was able to review the photo of an emerald 3ml from lot # 0.0317490, regarding item # 302986 with the reported issue of ¿3ml sterile syringe with plastic protective packaging that is not completely transparent¿.The dhr of lot number 0.0317490 was reviewed and there was no quality notification reported on this lot on any of the processes from its production to dispatch.No samples and one photograph has been received by bd bawal and is available for investigation.Ten retention samples of lot number 0.0317490 were also used for investigations.Samples were analyzed under smart scope.The prima facie evidence from the smart scope looks like the cloudiness in the inner side of the cavity cover of the syringe is a cold formation issue which is caused during the primary packaging process.The other test conducted on the samples received were visual testing for presence of moisture and microbiological culture testing for presence of bacteria.There was no moisture found on the received sample inner cavity.The microbiological culture plate did not show growth of any biological agents ruling out any microbiological or moisture present on the inner side of the cavity that showed the cloudiness.We have further involved unit quality team to investigate these complaints and it was confirmed that the defect is a cold forming issue and does not impact the packaging integrity.H3 other text : see h10.

• Brand Name: SYRINGE 3ML LS EMERALD
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11787913
• MDR Text Key: 268231544
• Report Number: 2243072-2021-01360
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302986
• Device Lot Number: 0317490
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1