MAUDE Adverse Event Report: CAREFUSION, INC 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR; ANESTHESIA CONDUCTION KIT

Catalog Number	400866
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0001301412, medical device expiration date: 2021-03-31, device manufacture date: 2019-05-10.Medical device lot #: 0001284188, medical device expiration date: 2021-04-30, device manufacture date: 2019-01-30.Medical device lot #: 0001280749, medical device expiration date: 2021-04-30, device manufacture date: 2019-01-10.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that ineffective anesthesia occurred during use with a 25gx3.5in whit 5ml glaspak bupi clear.The following information was provided by the initial reporter, "it was reported that 2 more c/ sections with the incident date unknown took place and were performed where the crna had issue with the spinals anesthesia- bupivacaine being questionable as ineffective (lot # 0001280749).Then a week later 2 more c/ sections were performed, date of incident for this event is unknown at the moment and it involved two lot numbers (0001284188 & 0001301412).Per email: hi, here is the information for the complaint.Do you want to add this to the existing pr or create a new one? at this time we only have the tray lot information, we do not have the drug lot information.Recently started using new bd spinal kits (previously arrow).Last week, ob had two c/sections in which the spinals didn¿t take.Both spinals were put in by the same crna.The first c/s, he repeated the spinal which provided the patient relief.The 2nd c/s, he gave additional iv meds.A safety opportunity was entered for this, and after discussing these cases with the crna, we thought maybe the medication within the spinal kit was not as effective, so we pulled all spinal kits with that lot number (0001280749) from the ob stock and from general stores.Today, we had two more c/sections (different lot numbers than previously), and according to crna, he had issues with these spinals as well.He said he talked to the doctor about this, and the doctor indicated they were having an issue with these same spinal kits, and were pulling them from the shelves.Can you please check with the doctor on this? if they are having the same issues as we are, and the kits are being pulled, both locations should probably be doing the same.".
Additional Manufacturer Narrative
H.6.Investigation summary: a device history record review was performed for the provided lot numbers; 0001280749, 0001301412, and 0001284188.The review did not reveal any detected abnormalities during the manufacturing process for any of the three provided lots.A review of the temperature monitoring system within the manufacturing facility did not identify any excursions that could have negatively affected any of the raw material drug components used within this product.Although a sample was shipped for evaluation; unfortunately, the returned sample could not be located and is considered lost.If the sample is located, this record will be re-investigated by our quality team.Based on the investigation results, a definitive cause for this incident could not be determined.Our vendor has been made aware of this incident and our quality team will continue to monitor the production process for this defect and other emerging trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that ineffective anesthesia occurred during use with a 25gx3.5in whit 5ml glaspak bupi clear.The following information was provided by the initial reporter, "it was reported that 2 more c/ sections with the incident date unknown took place and were performed where the crna had issue with the spinals anesthesia- bupivacaine being questionable as ineffective (lot # 0001280749).Then a week later 2 more c/ sections were performed, date of incident for this event is unknown at the moment and it involved two lot numbers (0001284188 & 0001301412).Per email: hi, here is the information for the complaint.Do you want to add this to the existing pr or create a new one? at this time we only have the tray lot information, we do not have the drug lot information.Recently started using new bd spinal kits (previously arrow).Last week, ob had two c/sections in which the spinals didn¿t take.Both spinals were put in by the same crna.The first c/s, he repeated the spinal which provided the patient relief.The 2nd c/s, he gave additional iv meds.A safety opportunity was entered for this, and after discussing these cases with the crna, we thought maybe the medication within the spinal kit was not as effective, so we pulled all spinal kits with that lot number (0001280749) from the ob stock and from general stores.Today, we had two more c/sections (different lot numbers than previously), and according to crna, he had issues with these spinals as well.He said he talked to the dr.About this, and the dr.Indicated they were having an issue with these same spinal kits, and were pulling them from the shelves.Can you please check with the dr.On this? if they are having the same issues as we are, and the kits are being pulled, both locations should probably be doing the same,".

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9364281
• Report Number: 1625685-2019-00130
• Device Sequence Number: 516610
• Product Code: CAZ
• UDI-Device Identifier: 00382904008666
• UDI-Public: 382904008666
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (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): 01/21/2020

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
• Operator of Device: Other
• Device Catalogue Number: 400866
• Device Lot Number: SEE. H.10
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other