MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ NEEDLE 3/4 IN. SINGLE USE, STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305143
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown h.6.Investigation summary: it was reported there was leakage from the needle hub.As a sample was not returned, a thorough sample investigation could not be completed.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a needle assembly and what appears to be a hole in the needle hub.No other information could be obtained from the photo.As the lot provided is 'unknown,' a device history record review could not be completed.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that the bd¿ needle 3/4 in.Single use, sterile hub was cracked and leaking occurred.The following was received by the initial reporter: we have experienced leaks from the needle hub of 2 supplies: 22ga.Insyte autoguard and 23ga.Precisionglide needle.I don¿t have lot number information from each as they were in use and unable to track back to the original packaging.It appears to be leaking at a spot that is found on all bd products (various size needles and insyte autoguard).It may be that this spot/defect penetrates all the way through the side of needle hub as seen in the attached photo.Has this been reported or is there awareness of this issue? are there any products recalls to be aware of? in the field of nuclear medicine technology, this is problematic as we inject radiopharmaceuticals through these supplies.When they leak, it creates contamination to the patient skin, equipment and floor and the intended route of administration is not being delivered to the patient as required for imaging.

• Brand Name: BD¿ NEEDLE 3/4 IN. SINGLE USE, STERILE
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17935232
• Report Number: 1911916-2023-00772
• Device Sequence Number: 20425146
• Product Code: FMI
• UDI-Device Identifier: 00382903051434
• UDI-Public: 00382903051434
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 10/02/2023

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: Health Professional
• Device Catalogue Number: 305143
• Device Lot Number: UNKNOWN
• 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: 09/26/2023
• Initial Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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