MAUDE Adverse Event Report: INTEGRA YORK, PA INC. HALSTEAD FCPS 5 STR SATIN; N/A

Catalog Number 106100

Device Problem Defective Device (2588)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device history record review confirmed the labeling, material, and process controls were within specification.

Event Description

A customer reported that a 106100 halstead fcps 5 str satin was used while performing a central line placement to an infant.It was stated that the clamp cut through the unopened alcohol pad and the teeth of the clamp pierced the polyurethane catheter which caused the infant's arterial blood to leak from the line.It was also reported that they had to elevate the umbilical cord to enhance the placement of the catheter, the forceps were shredding the umbilical cord making it very difficult to place the line.A surgery delay of approximately 30 minutes was reported to get fluids started for this nicu admission and for the blood loss.Additional information has been requested.

Manufacturer Narrative

The device was returned to the manufacturer for physical evaluation.The failure mode was confirmed.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances noted during the manufacturing process.There were 9 halsted mosquito forceps returned in unused condition.The forceps were tested with artificial testing material for clamping; the forceps did not function as designed.When attempting to clamp the forceps, instead of gripping, they cut through the material.The complaint report has been confirmed; the root cause has been identified as a workmanship or material deficiency.Appropriate action has been implemented to rectify this manufacturing deficiency.

• Brand Name: HALSTEAD FCPS 5 STR SATIN
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 7424908
• MDR Text Key: 105294855
• Report Number: 2523190-2018-00048
• Device Sequence Number: 1
• Product Code: HDT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 106100
• Device Lot Number: 159842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/13/2018
• Supplement Dates FDA Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other