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

Model Number	0070400
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
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 upon checking, the stopper of the silicone bulb evacuator was damaged before use.
Additional Manufacturer Narrative
The reported event was confirmed and the cause was unknown.A potential root cause for this failure mode could be ¿no follow up to the good manufacturing practices¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "indications for use: wound drains are used to remove exudates from wound sites.A.Drain placement for 100cc, 200cc, and 400cc silicone evacuators 1.Place wound drain(s) within critical fluid collection areas.2.Draw non-perforated section of wound drain through skin until drain indicator mark appears at the skin surface.3.Attach non-perforated section of drain directly to evacuator inlet port.4.200cc and 400cc silicone evacuators: when using 2 silicone drains with one evacuator, clip sealed inlet port and attach second drain.B.Drain placement for all other evacuators 1.Place wound drain(s) within critical fluid collection areas.2.Draw non-perforated section of wound drain through skin until drain indicator mark appears at the skin surface.3.Attach non-perforated section of drain either to y-connector or directly to evacuator inlet port.4.With two silicone drains, attach blue adaptors to drains and y-connector, and attach y-connector to inlet port.Note: for 1/8¿ (3.2 mm) round drain, y-connector or enclosed 1/8¿ (3.2 mm) drain adapter must be used to connect to evacuator.Caution: do not puncture or perforate drain.C.With silicone round double drain 1.See instructions with drain.D.Attaching to auxiliary suction 1.Connect suction tube to empty port using a stepped 5-in-1 connector.2.During auxiliary suction, evacuator will deflate and exudate will flow through evacuator into suction tube.E.To establish suction 1.Open empty port.2.Squeeze evacuator.3.Close empty port.Note: reflux of fluid to the patient is minimized during reactivation by an anti-reflux valve in inlet port.F.To empty container 1.Open empty port over collection basin.2.Squeeze evacuator to empty.G.To re-establish suction 1.Repeat step ¿e¿ above.H.To read fluid volume 1.Invert unit.2.Open empty port to release vacuum.3.Read and record approximate volume.4.Empty and reactivate evacuator." the actual/suspected device was inspected.
Event or Problem Description
It was reported that upon checking, the stopper of the silicone bulb evacuator was damaged before use.

• Brand Name: SILICONE BULB EVACUATOR
• Common Device Name: SILICONE BULB EVACUATOR
• 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: 14435540
• Report Number: 1018233-2022-03907
• Device Sequence Number: 5646058
• Product Code: GCY
• UDI-Device Identifier: 00801741049491
• UDI-Public: (01)00801741049491
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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 Expiration Date: 08/31/2026
• Device Model Number: 0070400
• Device Catalogue Number: 0070400
• Device Lot Number: NGFV4202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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