MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES (ETHICON) SURGIFLO HEMOSTATIC MATRIX; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Model Number 2991

Device Problem Break (1069)

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

Event Date 10/04/2017

Event Type  malfunction  

Event Description

After opening the package of surgiflo, the syringe was broken.It was found broke when package was opened.A new package of surgiflo opened and everything was fine.

• Brand Name: SURGIFLO HEMOSTATIC MATRIX
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES (ETHICON); shikha gola; route 22 west; somerville NJ 08876
• MDR Report Key: 6954330
• MDR Text Key: 89499506
• Report Number: 6954330
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2018
• Device Model Number: 2991
• Device Lot Number: 249783
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 64 YR
• Patient Weight: 82