MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC W/STIFFENING STYLET BASIC TRAY 30CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer via medwatch "one week old neonate in the nicu had a picc line placed.On (b)(6) 2022, picc line was ordered to be pulled back 3cms.Infant dressing removed per protocol using dressing change kit and wearing sterile gloves, hat, mask, and goggles.Upon removal of tegaderm, the line appeared intact, but when removing white hub guard near insertion site line found to be in two pieces around the 4 cm mark.Part of line still attached to hub guard and part of line was free.Line grabbed with tweezers and slowly removed.Full length of catheter accounted for upon removal.Second picc nurse to bedside to assess.Medical team made aware of findings.Ordered piv to be inserted and dose of vancomycin given.New picc line to be inserted later that day." additional information received 12/09/2022: patient required additional procedure for new line placement.Patient is a preemie and being treated for genetic and cardiac d/o, no infectious disease.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refz2107 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refz2107) have been reported from the same facility.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC W/STIFFENING STYLET BASIC TRAY 30CM
• 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: 16044722
• Report Number: 3006260740-2022-05868
• Device Sequence Number: 12328795
• Product Code: LJS
• UDI-Device Identifier: 00801741074837
• UDI-Public: (01)00801741074837
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4132105
• Device Lot Number: REFZ2107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: Required Intervention
• Patient Age: 11 DA
• Patient Sex: Female