MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD CONVENTIONAL NEEDLES; NEEDLES, HYPODERMIC

Catalog Number	305891
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd conventional needles safety shield broke off.The following information was provided by the initial reporter translated from dutch to english: we received the following complaint from one of our customers: we would hereby like to inform you of the finding of one of our youth doctors.Can you indicate whether there have been multiple reports of this ¿complaint¿? today i wanted to close a bd eclipse needle, but the pink cap broke off.(b)(6).¿ could you please provide a date of event? (b)(6) 2024 ¿ we would like you to confirm if any samples are available for investigation.If yes, could you please specify if the samples are: - unused (before use) - used (during or after use) product was used to vaccinate.Could be contaminated with blood.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305891 and lot number 2407007.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, both picture samples and the affected physical sample were returned for evaluation by our quality team.Through examination of the samples, the safety shield was observed broken from the ¿pivot¿ area (plastic part which is directly assembled to the hub).The material used to manufacture the eclipse needles has been selected and tested to resist normal conditions of use.In addition, our assembly process has a system in place which inspects all product for proper opening and activation of safety shields, rejecting any defects identified.Every lot produced is tested for final safety shield activation testing before release.Based on the preventive measures in place, we believe the probability of this defect is very low with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD CONVENTIONAL NEEDLES
• Common Device Name: NEEDLES, HYPODERMIC
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20580099
• Report Number: 3002682307-2024-00231
• Device Sequence Number: 18166807
• Product Code: FMI
• UDI-Device Identifier: 50382903058919
• UDI-Public: (01)50382903058919(11)240627(17)290630(10)2407007
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: 305891
• Device Lot Number: 2407007
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown