MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SPINAL ANESTHESIA KIT; NEEDLE, CONDUCTION, ANESTHETI

Catalog Number	ASA-25090-SB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "when spinal needle removed (c-section prep), approximately 4-5 cm of needle missing, broken off in patient.Required new spinal.Removal done of the rfb (needle) after delivery of the baby.Separate procedure." additional information was requested from the customer, however no additional information has been provided at this time.
Additional Manufacturer Narrative
(b)(4).Additional information received 05jun2024 states "needle recognized broken off immediately; needle removed with no issues; as stated.The patient is fine.The fact that the needle broke on this routine matter prompted us to voluntarily report." complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Corrected data: section d.4.- unique identifier (udi)# corrected to (b)(4).
Event or Problem Description
It was reported "when spinal needle removed (c-section prep), approximately 4-5 cm of needle missing, broken off in patient.Required new spinal.Removal done of the rfb (needle) after delivery of the baby.Separate procedure.".

• Brand Name: ARROW SPINAL ANESTHESIA KIT
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETI
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19467699
• Report Number: 9680794-2024-00544
• Device Sequence Number: 7452409
• Product Code: BSP
• UDI-Device Identifier: 50801902074190
• UDI-Public: 50801902074190
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K911260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: ASA-25090-SB
• Device Lot Number: 33F23H0235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 06/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White