MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PORTEX NRFIT EPIDURAL CONTINUOUS MAXIPACK TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number	24-1305-22
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 20ml syringe in the pack was used to give a top up epidural prior to emergency caesarean section, and the syringe split/burst.The spit occurred at the top of the syringe near where it was connected to the epidural filter.It was a critical moment that the syringe split, resulting in a delay of giving a top up epidural.When the top up failed, the baby needed to be born so a decision was made to use general anesthesia (ga).This resulted in the woman not being awake for the birth of her baby and the dad not being present in theatre.There was patient involvement and patient harm.The patient required a general anesthesia emergency lower segment cesarean section rather than an epidural top up.The patient received the following medical treatment: ga, pca pump post-delivery.This occurred with two separate patients.This report captures the first of two patients.
Additional Manufacturer Narrative
Date of event: unknown.No information has been provided to date.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6.Codes: updated.The investigation into this complaint was completed based on two photos provided by the customer.On examination of the photos there is a visible light in place, which is possibly the reported crack.The crack of the syringe was possibly caused by an excessive force that was applied on it.Unfortunately, without a sample we are unable to further investigate, and the root cause of this incident remains unknown.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: PORTEX NRFIT EPIDURAL CONTINUOUS MAXIPACK TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; 52 grayshill road, westfield; cumbernauld G68 9 HQ; UK G68 9HQ
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20640824
• Report Number: 3010189764-2024-00006
• Device Sequence Number: 18014412
• Product Code: CAZ
• UDI-Device Identifier: 15019517070347
• UDI-Public: (01)15019517070347
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 24-1305-22
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown