MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F SINGLE-LUMEN 65CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
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 recx2384 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported jugular r was punctured, presented good blood flow, metallic sheath (mandrel) was removed, catheter was introduced, progressing easily.But the introducer broke before inserting the catheter.Info added on (b)(6) 2021: was there any harm to the patient? there was the interruption of the procedure, and the technique adopted was providing another catheter.The icu is near by the pharmacy, and the nurse was quick in process.Was there a need for medical and/or surgical intervention due to what happened (imaging exams, surgery, medication administration, etc)? there was none, only the puncture was restarted.

• Brand Name: PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F SINGLE-LUMEN 65CM
• 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: 12380406
• Report Number: 3006260740-2021-03585
• Device Sequence Number: 19935173
• Product Code: LJS
• UDI-Device Identifier: 00801741074905
• UDI-Public: (01)00801741074905
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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 Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 4135105
• Device Lot Number: RECX2384
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/27/2021
• 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