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

Catalog Number	0071440
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that the perforated potion of the drain remained in the wound after the drain was removed.The drain was inserted (b)(6) 2017.It was later reported that the patient was scheduled for a radical left groin dissection revision for clear margins.While re-excising the previous incision, the surgeon found a portion of retained drain in the wound.It appeared that the drain had separated.The white portion of the drain was found in the wound and removed by the surgeon.
Additional Manufacturer Narrative
A photo sample was returned for evaluation.The reported event was confirmed as a manufacturing related issue.The visual evaluation of the photos noted that the flat drain was disconnected from the clear tube.The flat drain and clear tube not molded correctly; can be confirmed that the reported issue occurred during flat drain molding process.The lot number is unknown; therefore, the device history record could not be reviewed.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.
Event or Problem Description
It was reported that the perforated potion of the drain remained in the wound after the drain was removed.The drain was inserted (b)(6) 2017.It was later reported that the patient was scheduled for a radical left groin dissection revision for clear margins.While re-excising the previous incision, the surgeon found a portion of retained drain in the wound.It appeared that the drain had separated.The white portion of the drain was found in the wound and removed by the surgeon.

• Brand Name: CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR, HUBLESS SILICONE FLAT DRAIN, 10MM
• Common Device Name: FLAT SILICONE DRAIN
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6521657
• Report Number: 1018233-2017-02076
• Device Sequence Number: 248637
• Product Code: GCY
• UDI-Device Identifier: 00801741049675
• UDI-Public: (01)00801741049675
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

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 Catalogue Number: 0071440
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 06/01/2017
• 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