MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number VP556X

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during cardiac surgery, the device was used on the patient and had inadequate tensile strength and was easily torn.The product was discarded to resolve the issue.There was no patient injury.

Manufacturer Narrative

Evaluation summary post market vigilance (pmv) led a photographic evaluation of one image and a film of the device.Photographic inspection noted four needles and two suture.One suture and two needles were noted inside a breathable pouch and retainer of the product.Photographic and film evaluation noted two needles and two partial sutures.One needle attached to a partial suture each.The broken end of the partial sutures were split into two ends each.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO II
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8370091
• MDR Text Key: 137143459
• Report Number: 9612501-2019-00351
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 10884521037892
• UDI-Public: 10884521037892
• Combination Product (y/n): N
• PMA/PMN Number: K050947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VP556X
• Device Catalogue Number: VP556X
• Device Lot Number: D6L9329X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 23