MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 30ML LL S/C 56; SYRINGE, PISTON

Catalog Number 302832

Device Problem Break (1069)

Patient Problem Skin Tears (2516)

Event Date 03/12/2024

Event Type  malfunction  

Event Description

Material #:302832 batch#:3352922.It was reported by customer that the incident in the operating room on 3/12 that resulted in a syringe breaking in dr.(b)(6) hand.This resulted in him cutting his hand on the sharp plastic.Verbatim: we had an incident in the operating room on 3/12 that resulted in a syringe breaking in dr.(b)(6) hand.This resulted in him cutting his hand on the sharp plastic.

Manufacturer Narrative

Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Manufacturer Narrative

Pr (b)(4) follow up for device evaluation.It was reported the syringe broke and cut the dr's hand.To aid in the investigation, one sample in an opened packaging blister was received for evaluation by our quality team.A visual inspection was performed, and the syringe barrel is damaged at the flange.No other defects or imperfections were observed.This defect could occur if there was a jam during the assembly process.A device history record review was completed for provided material number 302832, lot 3352922.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Verification of the assembly process was performed.The alignments of rails and conveyors were correct, and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

Event Description

Additional information received dr.(b)(6) received a cut on his middle finger due to the syringe breaking.He was able to clean the wound and continue working for the remainder of his day.Material #:302832.Batch#:3352922.It was reported by customer that the incident in the or on 3/12 that resulted in a syringe breaking in dr.Finley's hand.This resulted in him cutting his hand on the sharp plastic.Verbatim: we had an incident in the or on 3/12 that resulted in a syringe breaking in dr.(b)(6) hand.This resulted in him cutting his hand on the sharp plastic.Additional information: dr.(b)(6) received a cut on his middle finger due to the syringe breaking.He was able to clean the wound and continue working for the remainder of his day.

• Brand Name: SYRINGE 30ML LL S/C 56
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18958635
• MDR Text Key: 338772054
• Report Number: 1911916-2024-00207
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028321
• UDI-Public: (01)30382903028321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 302832
• Device Lot Number: 3352922
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1