MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305145
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 4-5 bd precisionglide¿ needles were clogged during the injection.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "we have had an issue with the bd precisionglide needle.Randomly these needles will not allow for the injection to go through and will appear "clogged".Are you able to provide the quantity of defective needles? it is random and not all of the same lot number are affected.Has been probably 4-5 needles per day for the past 2-3 weeks.What was the animal¿s outcome? was there any adverse event or serious injury reported? none yet, today the actually needle disconnected from the plastic hub during a cystocentesis which could have caused serious injury if the va was not able to retrieve the needle part with her fingers from the skin of the patient.Was there any visible blockage? if yes, kindly describe.No visible blockage seen.Was this noted on the first use? yes they are brand new needles from the packaging being used for the first time with these occurrences.Were you able to draw up solution and then unable to expel? no, the needles were changed after drawing up with a different one so answer unknown.What medication was used during the event? vaccines, rabies, dapp, dapp/lepto, fvrcp, etc.What type of procedure is being performed? injection of vaccines, cystocentesis".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 17-may-2023 h6: investigation summary it was reported the needle will not allow the injection to go through.To aid in the investigation, two samples with no packaging blisters were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.The solution could not be expelled; the needles are clogged.A device history record review was completed for provided material number 305145, lot 2279794.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.There are quality controls currently in place to detect this type of defect during the production process such as a vision system that inspects 100% of all products for clogged needles.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.See h10.
Event or Problem Description
It was reported that 4-5 bd precisionglide¿ needles were clogged during the injection.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "we have had an issue with the bd precisionglide needle.Randomly these needles will not allow for the injection to go through and will appear "clogged".1.Are you able to provide the quantity of defective needles? it is random and not all of the same lot number are affected.Has been probably 4-5 needles per day for the past 2-3 weeks 2.What was the animal¿s outcome? was there any adverse event or serious injury reported? none yet, today the actually needle disconnected from the plastic hub during a cystocentesis which could have caused serious injury if the va was not able to retrieve the needle part with her fingers from the skin of the patient.3.Was there any visible blockage? if yes, kindly describe.No visible blockage seen 4.Was this noted on the first use? yes they are brand new needles from the packaging being used for the first time with these occurrences.5.Were you able to draw up solution and then unable to expel? no, the needles were changed after drawing up with a different one so answer unknown 6.What medication was used during the event? vaccines, rabies, dapp, dapp/lepto, fvrcp, etc.7.What type of procedure is being performed? injection of vaccines, cystocentesis".

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16947337
• Report Number: 1911916-2023-00313
• Device Sequence Number: 2252496
• Product Code: FMI
• UDI-Device Identifier: 00382903051458
• UDI-Public: 00382903051458
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 05/23/2023

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: 305145
• Device Lot Number: 2279794
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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
• Patient Sex: Unknown