MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC; 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	04/07/2022
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 refq3479 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported during passage of picc catheter, the introducer did not progress.Burrs were seen.During the procedure of passing the picc catheter, the guide wire was introduced into the patient's vein and when the dilator was introduced it did not progress even with all the procedural techniques, we visualized burrs on the tip of the dilator.Device has been discarded due to biological contamination.
Additional Manufacturer Narrative
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 damaged microintroducer sheath is confirmed; however, the exact cause is unknown.One photograph of a 5 fr microintroducer was returned for evaluation.An initial visual observation of the photograph showed the distal edge of the microintroducer sheath was damaged.No damage could be seen on the dilator tip and no blood residue was observed on the sample in the returned photograph.While the cause of the damage observed on the sample in the returned photograph could not be determined, possible contributing factors include insertion technique and advancement against resistance.
Event or Problem Description
It was reported during passage of picc catheter, the introducer did not progress.Burrs were seen.During the procedure of passing the picc catheter, the guide wire was introduced into the patient's vein and when the dilator was introduced it did not progress even with all the procedural techniques, we visualized burrs on the tip of the dilator.Device has been discarded due to biological contamination.Additional information received: was there any harm to the patient/health worker? a: no damage was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc.)? a: no intervention required.What treatment was the patient undergoing? a: post-surgical patient (lower limb amputation) being treated with teicoplanin and meropenem.Is there any relevant medical history or concomitant therapy? a: no.

• Brand Name: POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14655972
• Report Number: 3006260740-2022-02215
• Device Sequence Number: 11978794
• Product Code: LJS
• UDI-Device Identifier: 00801741027666
• UDI-Public: (01)00801741027666
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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 Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 3175118
• Device Lot Number: REFQ3479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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