MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/16/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refw0195 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported, during flushing the groshong, picc was teared off.Patient status/intervention is okay.22 december 2023 additional information received: it was reported by the customer "when the patient came in for his regular chemotherapy on (b)(6) in tmc, the nursing team was trying to flush the line with ns, at the same time, the flushing liquid was pouring out from the insertion site.Then, the nurse opened his tagadum bandze wrap of the patient and seen the outer part of the picc was teared off from the body about 3cm, rest of the line was inside body of the patient.X-ray was used to verify broken piece in patient.Patient did not require surgery to remove broken piece, fluroscopy done.All broken pieces were removed from patient.There is no long-term harm reported.

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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter break is confirmed.One assembled 4 fr groshong nxt catheter was returned for evaluation.The catheter was returned in two segments with one of the segments being assembled to the two-piece connector.The break was located near the 35 cm depth marker.Microscopic inspection of the break location revealed the catheter to be compressed at the tip forming an oval shape.An additional crease caused by kinking was noted 7 mm proximal to the break location.The crease appeared to be in the early stages of initiating a partial split.The break surfaces were granular and uneven.The break edges appeared to have evidence of material wrinkling caused by kinking.The catheter wall thickness was measured distal to break location.The catheter dimensions were found to be within manufacturing specification.The reported event description indicates the device was in use for over two months which suggest a manufacturing related root cause is unlikely.Based on the characteristics of the damage observed and location at which it occurred, repeated kinking of the catheter leading to material fatigue likely contributed to fracturing of the catheter.Handling of the device during use and securement of the catheter may also be contributing factors.Since a complete break in the catheter was found to be present, the complaint is confirmed.

Event Description

It was reported, during flushing the groshong, picc was teared off.Patient status/intervention is okay.22 december 2023 additional information received: it was reported by the customer "when the patient came in for his regular chemotherapy on dec.16 in tmc, the nursing team was trying to flush the line with ns, at the same time, the flushing liquid was pouring out from the insertion site.Then, the nurse opened his tagadum bandze wrap of the patient and seen the outer part of the picc was teared off from the body about 3cm, rest of the line was inside body of the patient.X-ray was used to verify broken piece in patient.Patient did not require surgery to remove broken piece, fluroscopy done.All broken pieces were removed from patient.There is no long-term harm reported.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16102950
• MDR Text Key: 306707794
• Report Number: 3006260740-2022-05992
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• UDI-Public: (01)00801741035272
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• 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: 7655405
• Device Lot Number: REFW0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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
• Patient Sex: Male