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

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regp1722 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported during the installation of a picc line the peelable sheath opened incorrectly during removal and trapped the catheter in place in the orange part.The technician had to break this hard part with a scalpel at the risk of cutting the catheter.There were no patient consequences.The picc remained in place.

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), applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty splitting a microintroducer was confirmed and appears to be manufacturing related.One 4.5 fr x 10 cm microez microintroducer was returned for evaluation.The grey sheath was fully peeled and the dilator was not returned.Blood residue and evidence of use was present on the device.One of the orange peel tabs was found to contain a concentric ring of material at the splitting interface.The material present on the tab was not even with the material present on the second tab.The uneven split of the tabs and presence of a ring in the material likely contributed to the difficult removal of the tab from the catheter; 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 h.11.

Event Description

It was reported during the installation of a picc line the peelable sheath opened incorrectly during removal and trapped the catheter in place in the orange part.The technician had to break this hard part with a scalpel at the risk of cutting the catheter.There were no patient consequences.The picc remained in place.

• Brand Name: POWERPICC SOLO 4F SINGLE-LUMEN CATHETER 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15556538
• MDR Text Key: 306496289
• Report Number: 3006260740-2022-03920
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 6194355
• Device Lot Number: REGP1722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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