MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY (3; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

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 be evaluated.Results are expected soon.A lot history review (lhr) of rebq1247 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebq1247) have been reported from the same facility.
Event or Problem Description
Per sales rep, the facility reported that during priming of the catheter it leaked, squirting out saline.
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 in the per-q-cath piccs was confirmed, but where or when the catheter was damaged cannot be verified.Two 2 fr per-q-cath piccs were returned for evaluation.The samples were marked #1 and #2.The piccs were received with the stylet in the lumen.The catheter length had not been modified; however, the stylet had been repositioned within sample #1.A functional test revealed leaks in the 2 fr tubing.On sample #1, leaks were observed near the 1cm depth mark.On sample #2, a leak was observed near the 6cm depth mark.The leak sites were microscopically examined and splits were found on the external surface of the tubing.The adjoining surfaces of the split tubing revealed a granular appearance.This type of split can occur when the catheter is compressed against the stylet.The catheter may have been compressed against the stylet while in transit, storage, or preparation for insertion.The product ifu states, ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.¿ manipulation of the stylet within the lumen can also damage the catheter is the stylet is not wetted prior to repositioning.The ifu indicates to never use force to remove stylet.Resistance can damage the catheter.A lot history review (lhr) of rebq1247 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebq1247) have been reported from the same facility.
Event or Problem Description
Per sales rep, the facility reported that during priming of the catheter it leaked, squirting out saline.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY (3
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6870086
• Report Number: 3006260740-2017-01644
• Device Sequence Number: 1222073
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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: 07/31/2018
• Device Model Number: 4132100
• Device Catalogue Number: 4132100
• Device Lot Number: REBQ1247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1