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	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material# 309626 batch# 3251983 it was reported that the bd syringe 1ml s/t w/ndl 25x5/8 rb needle was through the shield.The following information was provided by the initial reporter: "syringe was unpackaged as staff noticed that the needle has penetrated the cap." verbatim: rcc received a complaint via email.Email(s) attached.Gpoid: h002711 coid: a0511 contract number: 132 manufacturer: bd medical dear vendor, please review and provide a response to the product quality issue reported.Please contact the facility directly for details, sample collection and resolution.When the investigation has completed, please provide healthtrust with a copy of the final letter in order to close out the ticket in the healthtrust database.I will follow up with you for a status update in a couple of weeks.Facility contact: (b)(6).Product catalog number: 309626 product description: luer slip tip syringe with attached needle 25 g x 5/8 in., sterile, single use, 1 ml origin of the issue: staff safety detail: syringe was unpackaged as staff noticed that the needle has penetrated the cap number of occurrences: 1.0 sample available: true lot number: 3251983.
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• 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: 19169784
• Report Number: 1213809-2024-00244
• Device Sequence Number: 7949663
• Product Code: FMF
• UDI-Device Identifier: 30382903096269
• UDI-Public: (01)30382903096269(11)230908(17)280831(10)3251983
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/30/2024

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: Other
• Device Catalogue Number: 309626
• Device Lot Number: 3251983
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown