MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SL PICC W/SAFETY EXCALIBUR INTRO PUNCTUR-GUARD TECH; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when placing the pqc, the customer pre-flushed the catheter and found a sand-hole near the distal end of the catheter.When pre-flushing the catheter, liquids were seen leaking from the sand-hole.Upon receipt of the feedback from the customer, we have learned about the relevant information of the catheter and inquired and observed the operation details by the catheter placement operator.It was stated that there was no issue of improper placement of sharp instruments.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redw2590 showed four other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when placing the pqc, the customer pre-flushed the catheter and found a sand-hole near the distal end of the catheter.When pre-flushing the catheter, liquids were seen leaking from the sand-hole.Upon receipt of the feedback from the customer, we have learned about the relevant information of the catheter and inquired and observed the operation details by the catheter placement operator.It was stated that there was no issue of improper placement of sharp instruments.
Additional 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 review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed.One 4 fr per-q-cath with a t-lock and stiffening stylet inserted and one excalibur introducer in a sealed pouch were returned for evaluation.An initial visual observation showed use residue on the returned sample.A relatively large, curved split was observed in the catheter at the distal end of the strain relief.Approximately 41.8 cm of the stylet was found protruding from the t-lock within the catheter.A microscopic observation revealed the edges of the split to be mostly even, and the fracture surfaces of the split were found to be mostly flat, but quite rough and uneven.The catheter was dissected in order to inspect the inner walls of the catheter.A relatively large amount of abrasive damage was observed on the inner wall of the catheter around the area of the split.This abrasive damage within the catheter as well as the shape, texture, and location of the split indicate the catheter was likely damage due to excess friction from the stiffening stylet.As a note, the stylet must be properly hydrated prior to movement or manipulation of the stylet within the catheter.

• Brand Name: PER-Q-CATH PLUS 4F SL PICC W/SAFETY EXCALIBUR INTRO PUNCTUR-GUARD TECH
• 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
• 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: 13078721
• Report Number: 3006260740-2021-05417
• Device Sequence Number: 17155751
• 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: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: N/A
• Device Catalogue Number: 4134115
• Device Lot Number: REDW2590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown