MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 3ML LS BAWAL BP; PISTON SYRINGE

Catalog Number 302986

Device Problem Defective Component (2292)

Patient Problem Skin Tears (2516)

Event Date 06/15/2023

Event Type  malfunction  

Event Description

It was reported while using bd syringe 3ml ls bawal bp the wings were damaged.There was no report of patient impact.The following information was provided by the initial reporter: i was doing my injection yesterday but as the needle was already sunk into my muscle i noticed one of the 'wings' was broken.Because of this i couldn't really get a grip to push down, the plastic was cutting my finger and my injection took a lot longer than it usually would have.I use bd emerald 3ml syringes and i store them properly (in original packaging inside a metal box) and i think the syringe was broken before unwrapping.I think it's important these things get tracked so i've added a picture of the defect and the label with batch number.

Manufacturer Narrative

The manufacturing location for this product is bawal.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 17-jul-2023.H6: investigation summary samples and photos were received by bd for evaluation.A quality engineer was able to review the pictures and inspect the returned samples for the reported issue of ¿barrel / flange damaged¿ with lot number 1126276 regarding material number 302986.Barrel flange damage was observed in the photos and returned sample.The defect was confirmed.The device history review (dhr) of material number 302986 with lot number 1126276 was checked and there was no quality notification found on this lot number from its production date to its dispatch on date.The investigating team has also tested the retention samples of lot number 1126276 and material number 302986 for investigating the reported defect.No defect was observed in the retention samples.A review of the assembly and packaging processes was performed to determine the root cause of this defect.The probable causes of this defect include mishandling after manufacturing, not following the guides during assembly, and crushing the product while in packaging.H3 other text : see h10.

Event Description

It was reported while using bd syringe 3ml ls bawal bp the wings were damaged.There was no report of patient impact.The following information was provided by the initial reporter: i was doing my injection yesterday but as the needle was already sunk into my muscle i noticed one of the 'wings' was broken.Because of this i couldn't really get a grip to push down, the plastic was cutting my finger and my injection took a lot longer than it usually would have.I use bd emerald 3ml syringes and i store them properly (in original packaging inside a metal box) and i think the syringe was broken before unwrapping.I think it's important these things get tracked so i've added a picture of the defect and the label with batch number.

• Brand Name: BD SYRINGE 3ML LS BAWAL BP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17294031
• MDR Text Key: 318778522
• Report Number: 2243072-2023-01193
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302986
• Device Lot Number: 1126276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• 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