MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET MAXI; 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	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redt2323 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that picc line is leaking at the 1 cm mark.On 12/4/2019: nurse stated "there was no harm to the patient, but they went to the or specifically for picc placement, with a new piv being placed today to take picc out.Patient had ecoli uti and was placed for 2 weeks antibiotics.".
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, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking picc was confirmed but the exact cause was unknown.The product returned for evaluation was a 3fr s/l powerpicc sv.The catheter contained usage residue throughout and had been trimmed near the 16cm depth marking.Functional testing confirmed the presence of a small leak at the 1cm depth marker.Microscopic examination of the leak site revealed the presence of a 1mm split, which was oriented in the longitudinal direction.The split surfaces were dull, flat, and granular in nature and the exterior edges were sharply formed.Tactile evaluation of the catheter was unremarkable.The catheter damage was then cut from the catheter body and bisected longitudinally in order to inspect the inner catheter surface.The split was observed to reside within a small linear indentation in the catheter, but was otherwise unremarkable.The alleged deficiency could be confirmed, but insufficient evidence was available for determination of an exact root cause.A lot history review (lhr) of redt2323 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that picc line is leaking at the 1 cm mark.On (b)(6) 2019: nurse stated "there was no harm to the patient, but they went to the or specifically for picc placement, with a new piv being placed today to take picc out.Patient had ecoli uti and was placed for 2 weeks antibiotics.".

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET MAXI
• 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: 9512975
• Report Number: 3006260740-2019-03989
• Device Sequence Number: 17029669
• Product Code: LJS
• UDI-Device Identifier: 00801741087103
• UDI-Public: (01)00801741087103
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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 Model Number: N/A
• Device Catalogue Number: 1173108D
• Device Lot Number: REDT2323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 MO