MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER W/ SHERLOCK 3CG TPS STYLET 4F SL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refy3667 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "at the time of performing the insertion procedure, loss of the catheter's centimeter marking is identified, which is important to make it fit the patient.Another catheter had to be used.".

Event Description

It was reported "at the time of performing the insertion procedure, loss of the catheter's centimeter marking is identified, which is important to make it fit the patient.Another catheter had to be used." additional information received: it was stated there was no damage or injury presented to the patient.The medical device is changed for timely care.

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, applicable previous investigation(s), labeling, applicable manufacturing records, sample evaluation, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of missing catheter depth markings is confirmed and appears to be manufacturing related.The returned sample is a 4 fr sl ppicc catheter with 3cg stylet and t-lock assembly.The sample was returned in opened kit packaging indicating pn 4174118 and ln refy3667.The sample was returned with t-lock assembly attached and the stylet inside.An inspection of the catheter tubing revealed the depth markings to be missing after the 33 cm depth marker.The condition was likely caused during the printing manufacturing process; therefore, the complaint is confirmed.Bd is working closely with the manufacturing facility to prevent reoccurrence of the reported event.H3 other text: evaluation findings are in section h11.

• Brand Name: POWERPICC CATHETER W/ SHERLOCK 3CG TPS STYLET 4F SL
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15973560
• MDR Text Key: 307681670
• Report Number: 3006260740-2022-05694
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2023

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: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 4174118
• Device Lot Number: REFY3667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 02/25/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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): Other