MAUDE Adverse Event Report: BECTON DICKINSON 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR; ANESTHESIA CONDUCTION KIT

Catalog Number	400866
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material# 400866 batch# unknown.It was reported by customer that patient taken to or.Sab (subacrachnoid block aka spinal) placed with pre and post "swirl" of 1.2cc 0.75% bupiv.From kit with 250mg duramorph, patient noted bottom arm and getting numb (spanish speaking but able to indicate until interpreter communication established).Patient indicated pressure but no pain with foley but noted cold with alcohol used to wipe off jelly for fetal heart tones (first indication of issues), with prep patient noted a difference in temperature at approximately t-10, after draping patient noted a good amount of pressure on left but pain on midline (lud position), option of geta or epidural given and patient automatically elected epidural so we sat her up and the surgeon¿s (new xx doctor) and bard held her and epidural placed at same level with out difficulty, dosed with 10cc 2% with lido.With epi and bicarbonate, patient had surgical block by the time we were draped again.All this with a new surgeon (with bard assisting and wood observing" for credentialing) this was all done with the baby out and the uterus closed, not fascia though, by 9am and i don¿t believe we were in the room till 7:45 or after¿ just saying, it¿s always possible i hit the ureter but i¿m thinking it was the marcaine in the kit.No additional information could be obtained.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: several samples of stryker nostril retainer, which is a product that does not belong to bd, were provided.No photos or physical samples of the reported product have been received for investigation.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001529240 was performed and no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.We reviewed our sterilization records, no issues were identified during the sterilization process.The certification of analysis, provided to bd by the supplier has been reviewed for the reported lot, all testing done by the supplier verifies the product passed required inspections and is authorized for use.Based on the available information we are not able to identify a root cause related to our process that could impact the efficacy of the medication provided within our kits.The medication within the kit is provided by a supplier.We have notified the supplier of this incident.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20224187
• Report Number: 1625685-2024-00107
• Device Sequence Number: 12712993
• Product Code: CAZ
• UDI-Device Identifier: 50382904008661
• UDI-Public: (01)50382904008661(11)230810(17)250831(10)0001529240
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 400866
• Device Lot Number: 0001529240
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown