MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 4 FR. SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Model Number	4134105
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2017
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 rexc0823 showed no other similar product complaint(s) from this lot number.Device not returned, at this time.
Event or Problem Description
It was reported resistance of the introducer by passing through the skin.By removing it was observed that the tip of the introducer was splited.No patient injury was 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 damaged excalibur introducer sheath was confirmed, but the exact cause was unknown.One unsplit excalibur introducer sheath was returned for investigation.The sheath extended 3.1cm 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.The sheath was split 1.5mm along one of the score lines at the distal tip.This type of damage can occur if the sheath is advanced over the needle before it enters the vein.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.¿ a lot history review (lhr) of rexc0823 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported resistance of the introducer by passing through the skin.By removing it was observed that the tip of the introducer was splited.No patient injury was reported.

• Brand Name: PER-Q-CATH PLUS 4 FR. SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT
• 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: 6733484
• Report Number: 3006260740-2017-01114
• Device Sequence Number: 1607017
• Product Code: LJS
• UDI-Device Identifier: 00801741074875
• UDI-Public: (01)00801741074875
• 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,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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: 03/28/2018
• Device Model Number: 4134105
• Device Catalogue Number: 4134105
• Device Lot Number: REXC0823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR