MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	7755305
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/01/2018
Type of Reportable Event	Serious Injury
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, at this time, to the manufacturer for evaluation.A lot history review (lhr) of reau0943 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported the repair on the catheter disconnected and migrated.It required hemodynamic service for removal of the device.
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 catheter break was confirmed and the cause was determined to be use related.The product returned for evaluation was a 3fr groshong picc catheter which was separated from a connector assembly.Blood-like usage residue was seen throughout the sample and the proximal end of the catheter contained the jagged features consistent with a break.Microscopic examination of the fracture region revealed an overall concave shape to the catheter end with a granular surface.Mechanical damage was seen on the exterior surface of the catheter near the proximal end, which may have been related to removal of the embolized catheter.Tactile evaluation of the catheter revealed extreme tensile strength loss of the catheter shaft leading into the break site.From the observed damage, it was determined that the catheter had failed by a tensile (pulling) event.No potential manufacture contribution to the event was observed.A lot history review (lhr) of reau0943 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the repair on the catheter disconnected and migrated.It required hemodynamic service for removal of the device.

• Brand Name: GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER
• 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: 7456435
• Report Number: 3006260740-2018-00805
• Device Sequence Number: 1146672
• Product Code: LJS
• UDI-Device Identifier: 00801741037757
• UDI-Public: (01)00801741037757
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K926331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 7755305
• Device Catalogue Number: 7755305
• Device Lot Number: REAU0943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention