MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	4132100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebs2483 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the sales rep that the rn inserted the picc and after removing the stylet, a leak was noted at the 2cm mark.The picc was removed and another picc was placed successfully.No patient harm reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed and was determined to be use related.One 2 fr per-q-cath was returned for evaluation.An initial visual observation showed the catheter was returned in two segments.Blood residue was observed on the returned sample.The proximal segment of the catheter was flushed with a 12 ml syringe of water and a leak was observed approximately 2.1 cm distal to the distal end of the strain relief.A microscopic observation revealed a diagonal split in the catheter at the leak site.The split was observed to be mostly straight with one slightly curved corner.The sample was dissected in order to observe the inner wall of the catheter.The split appeared to be slightly more extensive on the inner surface of the catheter than the outer surface.What appeared to be abrasive damage could be seen on the inner wall opposite of the split.The damage observed on and within the catheter is typical of damage caused by excessive force or friction from a stylet.As a note, the product ifu states: ¿catheter stylet must be wetted prior to stylet repositioning or withdrawal¿ and ¿never use force to remove the stylet.Resistance can damage the catheter.If resistance or bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to normal shape.Withdraw both the catheter and stylet together approximately 2 cm and reattempt stylet removal.Repeat this procedure until the stylet is easily removed.Once the stylet is out, advance the catheter into the desired position.¿ a lot history review (lhr) of rebs2483 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the sales rep that the rn inserted the picc and after removing the stylet, a leak was noted at the 2cm mark.The picc was removed and another picc was placed successfully.No patient harm reported.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY
• 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: 7167975
• Report Number: 3006260740-2017-02379
• Device Sequence Number: 13476886
• Product Code: LJS
• UDI-Device Identifier: 00801741035210
• UDI-Public: (01)00801741035210
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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: 4132100
• Device Catalogue Number: 4132100
• Device Lot Number: REBS2483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1