MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 5F SINGLE-LUMEN PICC WITH SAFETY EXCALIBUR INTRODUCER PUNCTUR-GU; 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 Consequences Or Impact To Patient (2199)
Date of Event	01/25/2020
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 rebr1223 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that this patient was admitted to hospital on (b)(6) 2020 due to cerebral hernia as a result of head injury.At 15:00, catheter placement was performed, with 37 cm placed internally and another 6 cm exposed externally.At 9:00, (b)(6), a nurse observed rupture at joint between catheter and fitting (rupture externally).

• Brand Name: PER-Q-CATH PLUS 5F SINGLE-LUMEN PICC WITH SAFETY EXCALIBUR INTRODUCER PUNCTUR-GU
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10026961
• Report Number: 3006260740-2020-01637
• Device Sequence Number: 2986588
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 4135115
• Device Lot Number: REBR1223
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 40