MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number	309570
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd luer-lok¿ syringe with attached needle broke off while inserted into a dog's neck.Two x-rays were took after the incident and surgery was performed to remove the needle.The following information was provided by the initial reporter: we had a bd plastipak 3ml syringe with 25g x 5/8 needle, where the needle broke off under the pet's skin.I would like to make the company ( bd , becton, dickinson and company ) aware of this safety concern.It broke off at the hub's base.Additional info received on 3may2023: how did the hub break? the needle broke off at the hub base while inserted into a dog's neck for a jugular draw ; patient was spike ike, incident was (b)(6) 2023.When the break discovered? before use, during use or after use? during and after - when the sample was not flowing into the syringe.Is there any adverse event to the patient? he had to undergo a procedure to remove the needle from under skin, but he recovered completely.If you are unable to send a sample, can a photo be provided? attached are two x-rays we took immediately - following the discovery of the needle breaking off.
Additional Manufacturer Narrative
Correction h1: type of reportable events: malfunction.H5: imdrf annex f grid: f26.H6: investigation summary: two x-ray photos were provided to our quality team for investigation.Upon examination of the returned photo, it was observed that needle inserted in a body.Based on the investigation with the photo sample analysis the symptom reported is confirmed, but without the physical sample analysis a probable root cause could not be offered.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.
Event or Problem Description
It was reported that the bd luer-lok¿ syringe with attached needle broke off while inserted into a dog's neck.Two x-rays were took after the incident and surgery was performed to remove the needle.The following information was provided by the initial reporter: we had a bd plastipak 3ml syringe with 25g x 5/8 needle, where the needle broke off under the pet's skin.I would like to make the company ( bd , becton, dickinson and company ) aware of this safety concern.It broke off at the hub's base.Additional info received on 3may2023 how did the hub break? the needle broke off at the hub base while inserted into a dog's neck for a jugular draw ; patient was spike ike, incident was (b)(6) 2023.When the break discovered? before use, during use or after use? during and after - when the sample was not flowing into the syringe.Is there any adverse event to the patient? he had to undergo a procedure to remove the needle from under skin, but he recovered completely.If you are unable to send a sample, can a photo be provided? attached are two x-rays we took immediately - following the discovery of the needle breaking off.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16994784
• Report Number: 1213809-2023-00558
• Device Sequence Number: 12466127
• Product Code: FMF
• UDI-Device Identifier: 00382903095704
• UDI-Public: (01)00382903095704
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 309570
• Device Lot Number: 3047646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown