MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CHANNEL DRAIN, 15FR. ROUND HUBLESS FULL FLUTED WITH 4.7MM TROCAR; WOUND DRAIN

Catalog Number 072229

Device Problem Difficult to Insert (1316)

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

Event Date 07/20/2023

Event Type  malfunction  

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 Description

It was reported that customer wanted to ask if the bard 15fr drains with the trocars were new or if there was a change in product in the last few months.Customer struggled with getting the trocars to glide through the skin when inserting them.(lot#nghn2729 and lot#nghq2397).Per follow up via email on 25jul2023, customer stated that the trocar tip was nice and sharp.Issue occurred when pulling trocar through skin.It was extremely difficult the more it was fed through the skin, making the physician tug on the device with force.This could also result in a sharp stick.It was not safe to use.They also stated no patient harm.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.Visual evaluation of the returned sample noted four unopened (with original packaging), channel drain.Visual inspection of the sample noted the surface of the torcar was smooth and uniformed on the returned samples.This does meet specification which states that "drains must be smooth and not contain embedded bubbles or built-up material.".No root cause could be found because the reported event was unconfirmed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The reported event is unconfirmed a labeling review is not required.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 actual/suspected device was inspected.

Event Description

It was reported that customer wanted to ask if the bard 15fr drains with the trocars were new or if there was a change in product in the last few months.Customer struggled with getting the trocars to glide through the skin when inserting them.(lot#nghn2729 and lot#nghq2397).Per follow up via email on (b)(6) 2023, customer stated that the trocar tip was nice and sharp.Issue occurred when pulling trocar through skin.It was extremely difficult the more it was fed through the skin, making the physician tug on the device with force.This could also result in a sharp stick.It was not safe to use.They also stated no patient harm.

• Brand Name: CHANNEL DRAIN, 15FR. ROUND HUBLESS FULL FLUTED WITH 4.7MM TROCAR
• Type of Device: WOUND 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: 17479173
• MDR Text Key: 321244454
• Report Number: 1018233-2023-05874
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741049897
• UDI-Public: (01)00801741049897
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 072229
• Device Lot Number: NGHN2729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• 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