MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 25X5/8 RB; PISTON SYRINGE

Catalog Number	309626
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe 1ml s/t w/ndl 25x5/8 rb had a syringe needle connectivity issue.The following information was provided by the initial reporter: "when removing the cap the needle is detaching from the syringes." productcomplaint xxxx -rn reporting on her last day elon student health and wellness xxxxxx xxxxx email: xxxxx phone: xxxxx xxxxx email: xxxx (b)(6) issue: when removing the cap the needle is detaching from the syringes.Ref: (b)(4) lots: 3271607 doe: (b)(6) 2024 pt harm: no samples: yes.
Additional Manufacturer Narrative
It was reported, when removing the cap, the needle is detaching from the syringe.To aid in the investigation, two samples of 1ml slip tip syringes with needles from batch 3271607 was received for evaluation by our quality team.Both samples were received loose and fully disassembled; the shield of the needle was removed.No non-conformities were observed in the samples provided.It could be possible the customer is not tightening the needle onto the syringe prior to use.A device history record review was completed for provided material number 309626, lot 3271607.All visual inspections were performed per requirements, and there were no related quality notifications.Batch 3271607 was inspected and accepted based on meeting our inspection control plan and was subsequently approved for shipment.Additional device histories were reviewed for each batch of needles used in the manufacturing of this final batch.There was no documentation for this type of defect during the entire production run of these batches.To date, there have been no other similar events reported for this lot.No further action has been determined necessary at this time.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 1ML S/T W/NDL 25X5/8 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19029547
• Report Number: 1213809-2024-00197
• Device Sequence Number: 8029238
• Product Code: FMF
• UDI-Device Identifier: 30382903096269
• UDI-Public: (01)30382903096269(11)230928(17)281031(10)3271607
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 309626
• Device Lot Number: 3271607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown