MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR, HUBLESS SILICONE FLAT DRAIN, 10MM; WOUND DRAIN

Catalog Number	0071440
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "precautions: 1.Avoid suturing through the drains to minimize the possibility of breakage.2.Drains should lie flat and in line with the skin exit path.3.Particular care should be taken to avoid any obstacles to the drain exit path.4.Drains should be checked for free motion during closure to minimize the possibility of breakage during/after removal.5.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or blunt instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Warning: drain breakage may require surgical removal." (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
Event or Problem Description
It was reported that part of the drain ripped and a piece of the drain was left inside of the patient.An additional surgical procedure had to be performed in order to get the piece of the drain out of the patient.

• Brand Name: CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR, HUBLESS SILICONE FLAT DRAIN, 10MM
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6578669
• Report Number: 1018233-2017-02529
• Device Sequence Number: 953650
• Product Code: GCY
• UDI-Device Identifier: 00801741049675
• UDI-Public: (01)00801741049675(17)201231(10)NGZK4416
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 0071440
• Device Lot Number: NGZK4416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 05/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention