MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) (30 CM); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rexf1947 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
It was reported that catheter introducer presented rupture after the first attempt of puncture.
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 damaged excalibur introducer sheath was confirmed, but the exact cause was unknown.One unsplit excalibur introducer sheath was returned for investigation.The sheath extended 2.2cm from the distal end of the molded green tabs.The needle had been removed from the sheath and was not returned for investigation.The edge at the distal tip of the excalibur introducer sheath was rough and uneven.This type of damage can occur if the sheath is advanced over the needle before it enters the vein.A 0.022" x 0.019" piece of material was missing from the tip of the sheath.It is possible that the needle cut a portion of the sheath away from the distal tip.The damage most likely occurred during use.Without the needle, it cannot be determined if other factors were involved in the reported event.The product ifu states, ¿grip only on the needle hub during insertion.Do not apply excessive pressure to the wings.¿.
Event or Problem Description
It was reported that catheter introducer presented rupture after the first attempt of puncture.

• Brand Name: PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) (30 CM)
• 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: 6676557
• Report Number: 3006260740-2017-00926
• Device Sequence Number: 13837491
• Product Code: LJS
• UDI-Device Identifier: 00801741074820
• UDI-Public: (01)00801741074820
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

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: 07/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 4132005
• Device Lot Number: REXF1947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1