MAUDE Adverse Event Report: BECTON DICKINSON BD HYPOINT¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	300253
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that while using the bd hypoint¿ 25ga5/8in needle, leakage occurred.The following information was provided by the initial reporter: no mi involved.Caller was a female pharmacist.Pharmacist noted that a female patient in her 40s found a leakage from firazyr 30mg pfs (1 unit) while attempting to administer it at her home on (b)(6) 2024.Patient was only able to receive the half dose on the day.Pharmacist stated that the patient was prescribed firazyr 30mg pfs for hae caused by c1-esterase inhibitor deficiency.Patient administers firazyr 30mg pfs in a prn manner subcutaneously.Pharmacist stated that she is unable to provide further ae details on the line.Pharmacist stated that the firazyr 30mg pfs is currently at the patient's home, and she is not able to provide its batch number and expiry date.She stated that she will keep the the firazyr 30mg pfs in her hospital for quality investigation once the patient brings the firazyr 30mg pfs to the hospital on (b)(6) 2024.
Additional Manufacturer Narrative
H.6.Investigation summary: unconfirmed: no evidence provided.
Event or Problem Description
It was reported that while using the bd hypoint¿ 25ga5/8in needle, leakage occurred.The following information was provided by the initial reporter: no mi involved.Caller was a female pharmacist.Pharmacist noted that a female patient in her 40s found a leakage from firazyr 30mg pfs (1 unit) while attempting to administer it at her home on (b)(6) 2024.Patient was only able to receive the half dose on the day.Pharmacist stated that the patient was prescribed firazyr 30mg pfs for hae caused by c1-esterase inhibitor deficiency.Patient administers firazyr 30mg pfs in a prn manner subcutaneously.Pharmacist stated that she is unable to provide further ae details on the line.Pharmacist stated that the firazyr 30mg pfs is currently at the patient's home, and she is not able to provide its batch number and expiry date.She stated that she will keep the firazyr 30mg pfs in her hospital for quality investigation once the patient brings the firazyr 30mg pfs to the hospital on (b)(6) 2024.

• Brand Name: BD HYPOINT¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 19134032
• Report Number: 2243072-2024-00558
• Device Sequence Number: 20016751
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: 00382903002535
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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: Lay User/Patient
• Device Catalogue Number: 300253
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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