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	11/08/2017
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 no other similar product complaint(s) from this lot number.Device not returned yet.
Event or Problem Description
It was reported by the sales rep that the facility reported a hub disconnected from the catheter when priming after insertion into the patient.The catheter was removed and another device was placed.No reported patient injury.
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 catheter break was confirmed, and the cause appears to be use related.The implicated and returned product was a 2 fr s/l per-q-cath picc.The picc was received without the stylet.A break in the catheter was identified 1.4cm within the distal tip of the strain relief sleeve on the molded winged hub.A 22.1cm section of 2 fr tubing was received separate from the catheter hub.The break would have occurred external to the patient.The cross section at the proximal end of the distal catheter segment was microscopically examined and the surface was noted to be granular, dull, and uneven, which is consistent with characteristics of a break in the per-q-cath catheter material.A tactual investigation revealed a 1.5cm region of slight elastic weakness in the proximal end of the distal catheter segment, which indicates that the catheter was weakened from tensile stresses.The 2 fr tubing most likely broke subsequent to the catheter being stretched.It is unknown what caused the tubing to stretch.Care is suggested when handling the delicate size of the 2 fr tubing.Inadvertent stretching will cause the tubing to break.The product ifu provides securement techniques and a caution, which states, ¿to minimize the risk of catheter breakage and embolization, the catheter must be secured in place.¿ due to the condition of the returned sample, it appeared that the damage occurred during use.A lot history review (lhr) of rebt1329 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the facility reported a hub disconnected from the catheter when priming after insertion into the patient.The catheter was removed and another device was placed.No reported patient injury.

• 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: 7131778
• Report Number: 3006260740-2017-02269
• Device Sequence Number: 19100039
• 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: 12/22/2017
• 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