MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4F SINGLE LUMEN GROSHONG NXT CLEARVUE PICC WITH SHERLOCK TLS STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9655405
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2018
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 rezf0338 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that while reporter was flushing the patients picc line the flush allegedly started to come out of a hole in the line, above the insertion site.Picc allegedly leaking at the end of the clear connector.
Event or Problem Description
It was reported that while reporter was flushing the patients picc line the flush allegedly started to come out of a hole in the line, above the insertion site.Picc allegedly leaking at the end of the clear connector.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 leaking catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 4fr s/l groshong catheter.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The returned product sample was evaluated and a split was observed just distal of the two-piece connector.This catheter damage was typical of a burst, and the characteristics observed which supported this type of failure included: 'c' shaped split tensile weakness at the fracture site (due to material ballooning prior to burst).Granular fracture surface texture (typical of tearing failure modes).The catheter material was visibly lighter in color at the fracture site.The nursing procedure manual can be found online at (b)(6) and provides the following guidance: ¿do not use a syringe smaller than 10ml to flush or confirm patency.Patency should be assessed with a 10ml or larger syringe with sterile saline.Upon confirmation of patency, administration of medication should be given in a syringe appropriately sized for the does.Do not infuse against resistance.Infusion pressures should never exceed 25 psi.Smaller syringes generate more pressure than larger syringes.¿ the nursing procedure manual also provides guidance for re-establishing catheter patency in the event the catheter becomes occluded or resistance is felt during flushing.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of rezf0338 showed no other similar product complaint(s) from this lot number.

• Brand Name: 4F SINGLE LUMEN GROSHONG NXT CLEARVUE PICC WITH SHERLOCK TLS STYLET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7621124
• Report Number: 3006260740-2018-01452
• Device Sequence Number: 14062290
• Product Code: LJS
• UDI-Device Identifier: 00801741036026
• UDI-Public: (01)00801741036026
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K034020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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: 9655405
• Device Catalogue Number: 9655405
• Device Lot Number: REZF0338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1