MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 55 CM 5 FR. D/L GROSHONG NXT BASIC WITH MI AND TLS; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	Venipuncture (2129)
Date of Event	05/25/2017
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 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 crack in the catheter was confirmed and the cause appeared to be use related.The product returned for evaluation was a 5fr d/l groshong nxt picc.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 3mm split was observed which started 1mm from the molded joint and was associated with the red luered lumen.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 nursing procedure manual can be found online at www.Bardaccess.Com 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 rezj0538 showed three other similar product complaints from this lot number.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient's nurse had withdrawn blood from cvc for specimen collection.Syringe method was used for blood collection.As the nurse attempted to flush the picc with normal saline, she stated she saw a splash of fluid from the line.Upon inspection, she noted that one of the lumens of the picc line had fractured and there was a crack in it.She clamped the line and notified the avas team.The picc line had to be removed from the patient.The patient required a new insertion.

• Brand Name: 55 CM 5 FR. D/L GROSHONG NXT BASIC WITH MI AND TLS
• 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: 6656710
• Report Number: 3006260740-2017-00877
• Device Sequence Number: 11277531
• Product Code: LJS
• UDI-Device Identifier: 00801741036248
• UDI-Public: (01)00801741036248(17)171028(10)REZJ0538
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060341
• 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
• Report Date (Section B): 06/21/2017

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: 10/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 9957505
• Device Lot Number: REZJ0538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1