MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 5F SINGLE-LUMEN PICC WITH SAFETY EXCALIBUR INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redq0982 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on day 3 post catheter placement, a nurse found seepage beneath dressing when performing infusion using the catheter.After uncovering the dressing, the nurse found that the catheter ruptured at the root and removed the catheter.
Event or Problem Description
It was reported that on day 3 post catheter placement, a nurse found seepage beneath dressing when performing infusion using the catheter.After uncovering the dressing, the nurse found that the catheter ruptured at the root and removed the catheter.
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), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken catheter is confirmed.One 4 fr per-q-cath hubs and one segment of a 4 fr single lumen per-q-cath catheter tubing were returned for evaluation.An initial visual observation showed use residue on the returned samples.Tensile weakness was observed in the proximal end of the catheter segment.A microscopic observation revealed the break sites of the catheter hub and the proximal end of the catheter segment were mostly flat and granular in texture, and the two break sites were found to match.The location and characteristics of the break surfaces of the returned catheter as well as the presence of tensile weakness observed in the proximal end of the catheter segment indicate the catheter likely broke due to excessive tensile (pulling) force.H3 other text : evaluation findings are in section h.11.

• Brand Name: PER-Q-CATH PLUS 5F SINGLE-LUMEN PICC WITH SAFETY EXCALIBUR INTRODUCER
• 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: 11253175
• Report Number: 3006260740-2021-00159
• Device Sequence Number: 4279857
• Product Code: LJS
• UDI-Device Identifier: 00801741074929
• UDI-Public: (01)00801741074929
• 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,Followup
• Report Date (Section B): 04/05/2021

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: N/A
• Device Catalogue Number: 4135115
• Device Lot Number: REDQ0982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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