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

Model Number	CP-411
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, when preparing the operation, the scrub nurse wanted to take out the suture of the packaging, the needles were very hard to take out.When the needle was pulled out of the packaging, the needle and the thread separated from each other.It was reported that this happens quite often, that needles are very hard to pull out of the packaging.There was no patient involved.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of fourteen devices.Visual inspection of the opened samples noted two sutures and one needle.One of the sutures was returned with the needle disengaged.The needle was not returned.Visual inspection and functional testing of the sealed samples confirmed there were no abnormalities that would have caused or contributed to the reported condition.A needle attachment test was performed on the sealed samples and the results exceeded the specifications for this product.A review of the device history record indicates this product was 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
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7565373
• Report Number: 9612501-2018-01057
• Device Sequence Number: 19348599
• Product Code: GAW
• UDI-Device Identifier: 20884521036113
• UDI-Public: 20884521036113
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K954808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: CP-411
• Device Catalogue Number: CP-411
• Device Lot Number: D7H2189X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1