MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 04/11/2022

Event Type  Injury  

Event Description

It was reported "single lumen groshong picc was placed on (b)(6) 2022.Patient had been experiencing leaking and discomfort at the insertion site, so came to see our team this morning.It was noted with flushing that liquid was seeping out at insertion site.Dressing was removed and line pulled out approximately 2 cm until small leak was noted in the line at that point.Therefore, the leak in the line had been internal to the body.Picc was removed as repair of the line would have put the tip in suboptimal positioning in upper svc at best.' 'impact of incident: picc line was removed and new picc line inserted.Some minor skin breakdown from the leakage of antibiotic containing fluid on skin for extended period of time.Discomfort for the patient in his arm from the time the leaking started until resolution." additional information received 04/26/2022: "on the evening of (b)(6) 2022, patient noted that the picc insertion site was "wet".From what the patient tells us, home care came out to see him and changed the picc dressing, but was unable to determine the cause of the wetness.When the patient showered and had his arm in the air , while the infusion of piperacillin-tazobactam was infusing, he noted liquid actually running down his arm.He felt a feeling of "fullness" in his arm as well as an associated "foul" smell.He presented to our team the morning of (b)(6) 2022.When i flushed the picc line, there was noted leakage of liquid from the insertion site, but no noted leak from the picc line externally.I continued to flush the picc line as i withdrew the line, and the leak/fracture of the picc line was noted approximately 2 cm internal to the body.We use securacath to secure our picc lines.The existing picc line was removed and a new picc line inserted.".

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refs0054 showed three other similar product complaint(s) from this lot number.

Event Description

It was reported "single lumen groshong picc was placed on (b)(6) 2022.Patient had been experiencing leaking and discomfort at the insertion site, so came to see our team this morning.It was noted with flushing that liquid was seeping out at insertion site.Dressing was removed and line pulled out approximately 2 cm until small leak was noted in the line at that point.Therefore, the leak in the line had been internal to the body.Picc was removed as repair of the line would have put the tip in suboptimal positioning in upper svc at best.' 'impact of incident: picc line was removed and new picc line inserted.Some minor skin breakdown from the leakage of antibiotic containing fluid on skin for extended period of time.Discomfort for the patient in his arm from the time the leaking started until resolution." additional information received 04/26/2022: "on the evening of (b)(6) 2022, patient noted that the picc insertion site was "wet".From what the patient tells us, home care came out to see him and changed the picc dressing, but was unable to determine the cause of the wetness.When the patient showered and had his arm in the air , while the infusion of piperacillin-tazobactam was infusing, he noted liquid actually running down his arm.He felt a feeling of "fullness" in his arm as well as an associated "foul" smell.He presented to our team the morning of (b)(6) 2022.When i flushed the picc line, there was noted leakage of liquid from the insertion site, but no noted leak from the picc line externally.I continued to flush the picc line as i withdrew the line, and the leak/fracture of the picc line was noted approximately 2 cm internal to the body.We use securacath to secure our picc lines.The existing picc line was removed and a new picc line inserted.".

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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed.The product returned for evaluation was one 4fr s/l groshong catheter.Usage residues were observed throughout the sample and the catheter was assembled with the connector.A split was observed between the 38cm and 39cm depth markings (approximately 6cm from the connector).An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a leak was observed emanating from the split site.Microscopic inspection of the split revealed inward curving edges.The fracture surface exhibited a granular texture.Following longitudinal bisection of the sample in the vicinity of the split, inspection of the inside surface of the catheter wall revealed abrasion damage.The damage on the inside surface appeared more extensive than that observed on the outside surface.The split features and abrasion damage on the inside surface of the catheter were consistent with damage caused by contact between the catheter wall and the stylet.Such damage can occur if the stylet is not wetted prior to removal and if removal or manipulation of the stylet is conducted when the catheter is constrained.

• Brand Name: GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM
• Type of Device: 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14378129
• MDR Text Key: 291599323
• Report Number: 3006260740-2022-01722
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: 801(E)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91660417
• Device Lot Number: REFS0054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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): Required Intervention