MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SL STIFFING STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	4134115
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged introducer sheath was confirmed, but the exact cause was unknown.One 4fr s/l per-q-cath picc was returned for investigation.The picc was received with the stylet in the lumen.One unsplit excalibur introducer sheath was also returned for investigation.The needle had been removed from the sheath and was not returned for investigation.The distal tip of the sheath was damaged.The sheath length was 1.23 inches from the distal end of the green hub.A microscopic examination of the sheath revealed two splits in the distal end of the sheath material.A functional test revealed that the 4 fr tubing was able to pass through the sheath without restriction.The observed damage of the sheath can occur during insertion of the excalibur needle and sheath; however, the exact mechanism of damage could not be determined and no defects associated with the manufacturing process were observed on the returned sample.A lot history review (lhr) of redq0982 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the product was opened and checked before operation.Cracks were noted with the body of the introducer needle.The product was unusable.(b)(6) 2021 the returned device was found split during evaluation.

• Brand Name: PER-Q-CATH PLUS 4F SL STIFFING STYLET
• 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
• MDR Report Key: 11713545
• Report Number: 3006260740-2021-01486
• Device Sequence Number: 3832504
• Product Code: LJS
• UDI-Device Identifier: 00801741074899
• UDI-Public: (01)00801741074899
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2021

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: 4134115
• Device Catalogue Number: 4134115
• Device Lot Number: REDQ0982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other