MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number	7755305
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2016
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 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 damaged catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 3fr s/l groshong catheter.Usage residues were observed throughout the sample.The catheter was received in two segments which shared a complete break at the 27cm depth marking, between the sliding suture wing and the two-piece connector.Curved shape memory was observed in the vicinity of the break.Tactile inspection of the sample revealed severe tensile weakness in the vicinity of the break.Microscopic inspection of the break revealed slightly irregular, dully granular edges.The break region exhibited an elliptical cross-section.The break characteristics, curved shape memory and severe tensile weakness were consistent with damage caused by tensile stress.It appeared that the connector was pulled while the catheter was fixed in place, resulting in the observed break.Care should be taken when securing, accessing and maintaining catheters to avoid causing damage.A lot history review (lhr) of rezi0440 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was placed on (b)(6) 2016.In the morning two days after the placement, the catheter was reportedly found cut into two parts.The device was immediately removed and replaced in the operative room.

• Brand Name: GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER
• 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: 5524741
• Report Number: 3006260740-2016-00129
• Device Sequence Number: 405609
• Product Code: LJS
• UDI-Device Identifier: 00801741037757
• UDI-Public: (01)00801741037757(17)170930(10)REZI0440
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K926331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/23/2016

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: 09/30/2017
• Device Catalogue Number: 7755305
• Device Lot Number: REZI0440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR