MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CLOSED WOUND SUCTION

Catalog Number 0070740

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

It was reported that customers had some concerns about the sterility of the silicone closed wound suction evacuator.When the product was in the sterile packaging and squeezed, the air escaped from the package.When let go, the air re-enters the packaging.They could not visibly see any damage to the packaging or seal breakage.It seemed when they checked our inventory, all were from this lot, and they repeated the same outcome.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that customers had some concerns about the sterility of the silicone closed wound suction evacuator.When the product was in the sterile packaging and squeezed, the air escaped from the package.When let go, the air re-enters the packaging.They could not visibly see any damage to the packaging or seal breakage.It seemed when they checked our inventory, all were from this lot, and they repeated the same outcome.Per additional information received via sample form on 16aug2022, stated that the air was leaking from sterile package when pressed and it re-entered the sealed product.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was used for patient treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one unopened (within original packaging), unused silicone bulb evacuator.Visual inspection of the sample noted that the tyvek packaging was still completely sealed, with no interruptions in the seal.No holes, rips or tears were noted in the packaging.There was no indication of a sterile barrier breach.Also noted the bulb was squeezed to negative pressure and the (in-house) drain connected and placed in a reservoir of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the solution was returned into the evacuator as intended.No root cause could be found because the reported event was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required as the reported event was unconfirmed.Correction: h.H11:section a through f - the information provided by bd 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 bd.H3 other text : the actual/suspected device was inspected.

• Brand Name: CLOSED WOUND SUCTION
• Type of Device: CLOSED WOUND SUCTION
• 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: 15248696
• MDR Text Key: 303038453
• Report Number: 1018233-2022-06521
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0070740
• Device Lot Number: NGGP2625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other