MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) (30 CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	4132005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2018
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, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rezd0413 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported rupture of the catheter with no apparent cause.It was stated the standard protocol of handling was followed.No other information was provided.
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 broken per-q-cath catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 2fr s/l per-q-cath catheter.Usage residues were observed.The catheter was received in two segments which shared a complete break within the molded joint region.Curved shape memory was observed in the vicinity of the break.Microscopic inspection of the break site revealed a coarsely granular break surface.The catheter exhibited an elliptical cross-section at the break site.Tactile inspection of the sample revealed tensile weakness, necking and discoloration in the vicinity of the break.The break characteristics, tensile weakness, necking and discoloration were consistent with damage caused by tensile (pulling) stress.The location of the damage suggested that catheter securement, maintenance and access/de-access technique may have contributed.
Event or Problem Description
It was reported rupture of the catheter with no apparent cause.It was stated the standard protocol of handling was followed.No other information was provided.

• Brand Name: PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) (30 CM)
• 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: 7915743
• Report Number: 3006260740-2018-02608
• Device Sequence Number: 1539665
• Product Code: LJS
• UDI-Device Identifier: 00801741074820
• UDI-Public: (01)00801741074820
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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: 4132005
• Device Catalogue Number: 4132005
• Device Lot Number: REZD0413
• 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: 02/01/2019
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1