MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE ROUND DRAIN

Catalog Number	0070310
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/04/2023
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.H11: section a through f - the information provided by bd represents all 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 bd.
Event or Problem Description
It was reported that the customer asked if there was any device recommendations on what to do when the drain was difficult to remove.The patient had minimal drainage and it was appropriate to remove the device.The team was at the bedside, patient medicated for pain and device was then pulled out from the patient.However, the provider was meeting resistance and the tube was not coming out.Per follow up via email on (b)(6) 2023, customer stated that the item has been discarded.The patient was safe and well.Customer asked was there a strength test as to how much with the tube can handle.Was there a limit to how much the tube can be pulled before it breaks.And also asked was it best practice to place the drain on traction to help ease the device out form a wound.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "tissue growth into channels, user not aware of device limitations: -user does not verify that system is functioning properly throughout use".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: ¿silicone round drain instructions for use indications: wound drains are used to remove exudates from wound sites.Warning: when placing drain(s) care should be taken to ensure that the perforated portion of the wound drain lies completely within the confines of the wound.Read product insert provided with the closed wound evacuator for detailed instructions, warnings and precautions associated with the use of the evacuator device.To avoid the possibility of drain damage or breakage: ¿ additional perforations should not be made in the drains.¿ avoid suturing through drains.¿ drains should lie flat and in line with the skin exit areas.¿ particular care should be taken to avoid any obstacles to the drain exit path.¿ drains should be checked for free motion during closure to minimize the possibility of breakage.¿ drain removal should be done gently by hand.They should not be handled with pointed, toothed or sharp instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.¿ surgical removal may be necessary if drain is difficult to remove or breaks.Drain placement 1.Place perforated wound drain within the critical fluid collection area of wound.2.Draw non-perforated section of wound drain through to the outside until drain indicator mark appears at the skin surface.Two sets of indicator marks aid placement of the drain.3.Remove trocar only by cutting the drain one inch from end of trocar.4.Trim non-perforated section of drain to desired length.For bard® 100cc silicone and reliavac® 100 evacuators single drain placement 1.Remove adapter with connector from pouch.2.Insert adapter end into non-perforated section of drain.3.Insert connecting tube of drain to adapter port of evacuator.For two drain placement for bard® 100cc silicone evacuators 1.Attach second drain to adapter.2.Attach connecting tube of both silicone drains to the bard® y-connector (#0070790) and connect y-connector to evacuator drain port.For reliavac® 100 (use blue adapter in drain package and y-connector in evacuator package) 1.Cut off plug from closed arm of y-connector.2.Remove blue adapters from pouches.Insert into y-connector.3.Attach both drains to blue adapters.For reliavac® 400 and 3-spring evacuators single drain placement 1.Ensure open end of y-connector is open or cut to 1/4¿ mark.2.Remove blue adapter from pouch.Insert into y-connector.3.Attach drain to blue adapter.For two drain placement 1.Cut off plug from closed arm of y-connector.2.Remove blue adapter from pouch.Insert into y-connector.3.Attach both drains to blue adapters.Reuse precaution: this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.¿ correction: a,b h11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the customer asked if there was any device recommendations on what to do when the drain was difficult to remove.The patient had minimal drainage and it was appropriate to remove the device.The team was at the bedside, patient medicated for pain and device was then pulled out from the patient.However, the provider was meeting resistance and the tube was not coming out.Per follow up via email on 09aug2023, customer stated that the item has been discarded.The patient was safe and well.Customer asked was there a strength test as to how much with the tube can handle.Was there a limit to how much the tube can be pulled before it breaks.And also asked was it best practice to place the drain on traction to help ease the device out form a wound.

• Brand Name: SILICONE ROUND DRAIN
• Common Device Name: SILICONE ROUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17622734
• Report Number: 1018233-2023-06311
• Device Sequence Number: 7385959
• Product Code: GBX
• UDI-Device Identifier: 00801741049460
• UDI-Public: (01)00801741049460
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: 0070310
• Device Lot Number: NGHQ1421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown