MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, FULL FLUTED

Model Number	072189
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the edge of the silicone drain was broken off.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample were confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), silicone channel drain with trocar.Visual inspection of the sample noted the trocar point shield the broken off upon return.This does not meet specification per ip7600518, revision 21 which states "no cuts or tears are allowed on the surface of the drains".A potential root cause for this failure mode could be ¿drain was manufactured incorrectly (dimensions or material out spec, curing time not appropriate".The device history record review could not be performed without a lot number.The investigation is concluded, and no additional action is required at this time.The device was returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "indications: bard® channel drains, round and flat silicone, are indicated for use with selected bard evacuators for closed wound drainage following head and neck, orthopedic, abdominal, ent, ob/gyn, plastic, neurosurgery, thoracic and cardiovascular (channel drains only) procedures.Warning: when placing drain(s) care should be taken to ensure that the channeled 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: 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.Drains 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 a.Using a single silicone channel drain 1.Place channeled wound drain within critical fluid collection area of wound.2.For drains displaying numerical depth markers, draw non-channeled section of wound drain through to the outside until desired depth has been achieved.For drains without numerical depth markers, draw non-channeled section of wound drain through to the outside until desired drain depth has been achieved or until drain indicator dot appears at the skin surface.Drains displaying numerical depth markers are provided with an additional radiopaque ring to indicate the transition into the channeled portion.These radiopaque indications will appear perpendicular to each other under x-ray.(see ¿warning¿ above).3.Insert connecting tube of drain to a bard brand evacuator.Included adaptors may be required for attachment.B.Using two silicone channel drains 1.Repeat steps 1-2 above.2.Attach proximal ends of silicone drains to a bard y-connector and connect y-connector to evacuator drain port.Included adaptors may be required for attachment." h11: section a through f - 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.H3 other text: the actual/suspected device was inspected.
Event or Problem Description
It was reported that the edge of the silicone drain was broken off.

• Brand Name: SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, FULL FLUTED
• Common Device Name: SILICONE CHANNEL 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13666778
• Report Number: 1018233-2022-01046
• Device Sequence Number: 5466454
• Product Code: GBX
• UDI-Device Identifier: 00801741049712
• UDI-Public: (01)00801741049712
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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 Model Number: 072189
• Device Catalogue Number: 072189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown