MAUDE Adverse Event Report: CAREFUSION, INC BD¿ GLASPAK; INTRATHECAL ANAESTHESIA KIT

Catalog Number 405671

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd¿ glaspak had foreign matter inside the syringe.

Manufacturer Narrative

Investigation summary: one sample was received for evaluation.Sample evaluation confirmed the reported failure mode.¿5ml glass pack that¿s in the tray, the syringe in that pack has an extra glass tip inside the glass syringe.¿ a device history record review of all applicable manufacturing records for lot 0001250402 did not identify any issues that may have contributed to the reported failure mode.Investigation conclusion: the complaint investigation was able to confirm the reported failure mode; however, the glass syringe is manufactured at a sister facility.Root cause description: a probable root cause could not be identified for the mannford manufacturing facility based on the investigation results.Rationale: the investigation was not able to identify any corrective actions for this complaint.Based on the reported failure mode, a supplier quality notification was sent to the vendor (bd-brazil) to notify the vendor of the reported failure mode (extra glass tip in syringe).Likewise, the complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis (qda) process if an adverse trend is identified.

Event Description

It was reported that a bd¿ glaspak had foreign matter inside the syringe.

• Brand Name: BD¿ GLASPAK
• Type of Device: INTRATHECAL ANAESTHESIA KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8185495
• MDR Text Key: 131804174
• Report Number: 1625685-2018-00064
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: 00382904056711
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 405671
• Device Lot Number: 0001250402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other