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

Catalog Number	9957505
Health Effect - Clinical Code	Foreign Body Sensation in Eye (1869)
Date of Event	08/17/2016
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 rezi1161 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (rezi1161) have been reported from the same facility.Device not yet returned for evaluation.
Event or Problem Description
It was reported that the nursing staff assessed picc and patient complained of a cool sensation under skin which had not been felt previously.Picc had previously been assessed for a sluggish line.Picc was reportedly leaking and had to be removed as the line could not be repaired.Once the catheter was removed, it was noted that there was a pin hole at 47 cm.Secureacath was close to pin hole at 48 cm.
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, 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 5fr d/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 between the 46cm and 47cm depth markings.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.An occlusion was observed distal to the burst site, and this may have contributed to the failure.Forceful flushing against an occlusion can cause this type of failure.The product ifu states ¿catheters that present resistance to flushing and aspiration may be partially or completely occluded.Do not flush against resistance.If the lumen will neither flush nor aspirate and it has been determined that the catheter is occluded with blood, a declotting procedure per institution protocol may be appropriate.¿ an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.

• 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: 5971426
• Report Number: 3006260740-2016-00496
• Device Sequence Number: 958411
• Product Code: FOZ
• UDI-Device Identifier: 00801741036248
• UDI-Public: (01)00801741036248(17)170828(10)REZI1161
• 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,Followup
• Report Date (Section B): 08/31/2016

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: 08/28/2017
• Device Catalogue Number: 9957505
• Device Lot Number: REZI1161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2016
• Supplement Report FDA Received Date: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1