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	4132100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebt1329 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebt1329) have been reported from the same facility.Device not returned yet.
Event or Problem Description
It was reported by the sales rep that the facility reported the catheter "sprung" a leak while priming.Another device was used to complete the procedure.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 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 being primed.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 4 and 5 cm depth marks.The leak site was microscopically examined and a split was found on the external surface of the tubing.The split was at an angle in relation to the axis of the catheter.The length of the split was less than 1/2mm.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.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebt1329 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebt1329) have been reported from the same facility.
Event or Problem Description
It was reported by the sales rep that the facility reported the catheter "sprung" a leak while priming.Another device was used to complete the procedure.No patient harm reported.

• 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: 7132258
• Report Number: 3006260740-2017-02270
• Device Sequence Number: 11094865
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: REBT1329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1