MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERHOHN CATH CV PLACEMENT 6F W/ MICROINTRODUCER TL 50CM NITINOL GW; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refp4367 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "my customer let me know of a leaking powerhohn upon insertion earlier today.It was leaking at the suture wing right out of the box.It was placed in a patient, drew blood, and when they went to flush they stated that fluid shot out of that area." additional info.Received 02.11.2022: "left ij insertion of the 6fr triple lumen hohn cath.Line insertion went great and on final blood return check and flush, i noticed that the line was leaking where the suture wing and line meet or connect when the gray lumen was flushed.I flushed to confirm and the gray lumen was spraying saline.I then opened another kit and preformed a cath exchange for another 6fr triple lumen power hohn of the same lot number and the new line did not leak from any lumen.The red and white lumens did not leak when flushed only the gray on the original line.".
Event or Problem Description
It was reported "my customer let me know of a leaking powerhohn upon insertion earlier today.It was leaking at the suture wing right out of the box.It was placed in a patient, drew blood, and when they went to flush they stated that fluid shot out of that area." additional info.Received 02.11.2022: left ij insertion of the 6fr triple lumen hohn cath.Line insertion went great and on final blood return check and flush, i noticed that the line was leaking where the suture wing and line meet or connect when the gray lumen was flushed.I flushed to confirm and the gray lumen was spraying saline.I then opened another kit and preformed a cath exchange for another 6fr triple lumen power hohn of the same lot number and the new line did not leak from any lumen.The red and white lumens did not leak when flushed only the gray on the original line.
Additional Manufacturer Narrative
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.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed and appears to be manufacturing related.One 6 fr triple lumen powerhohn catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.Each lumen of the returned catheter was flushed and pressurized with a 12 ml syringe of water.When the grey lumen was flushed, a spraying leak was observed emanating from the catheter tubing just distal to the molded joint.A microscopic observation revealed the split in the catheter consisted of two smaller colinear splits, the most distal of which appeared to be superficial.The edges of these splits were observed to be somewhat rough, but straight.Whitening of the catheter material was observed along the edges of the splits, and the fracture surface of the complete split was found to be rough and uneven.The distal-most split was observed to be deeper on the interior of the catheter suggesting the damage may have originated from within the catheter lumen.The location and shape of the split observed in the returned sample, as well as the alleged out-of-box failure of the sample suggest the catheter may have been damaged during the manufacturing procedure.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.

• Brand Name: POWERHOHN CATH CV PLACEMENT 6F W/ MICROINTRODUCER TL 50CM NITINOL GW
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13602558
• Report Number: 3006260740-2022-00481
• Device Sequence Number: 20297657
• Product Code: LJS
• UDI-Device Identifier: 00801741036835
• UDI-Public: (01)00801741036835
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K093927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: N/A
• Device Catalogue Number: AVA33861
• Device Lot Number: REFP4367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 137 KG