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

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/16/2017
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 no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the sales rep that the picc nurse opened the picc packaging, connected a saline syringe to prime the picc, and noticed a leak.Product was not used on a patient, as it leaked prior to the procedure.
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 picc was confirmed, but how or when the catheter was damaged cannot be verified since it was reported that the leak was noted when the picc was flushed after opening the picc packaging and connecting a syringe.One 2 fr per-q-cath picc was returned for evaluation.The picc was received with the stylet in the lumen.A functional test revealed a leak in the 2fr tubing between the 6 and 7 cm depth marks.The leak site was microscopically examined and a curved split was 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 stylet is retracted without flushing the catheter.A hydrophilic coating on the stylet needs to be 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 rebs2483 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the sales rep that the picc nurse opened the picc packaging, connected a saline syringe to prime the picc, and noticed a leak.Product was not used on a patient, as it leaked prior to the procedure.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY
• 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: 7033303
• Report Number: 3006260740-2017-02029
• Device Sequence Number: 16680465
• 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): 01/19/2018

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: N/A
• Device Catalogue Number: 4132100
• Device Lot Number: REBS2483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1