MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV SP 3F SL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S9173108PD
Health Effect - Clinical Code	Venipuncture (2129)
Date of Event	03/12/2018
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that picc split in half where the hub meets the catheter; patient was not harmed, but line had to be removed and patient was stuck again.
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 detached hub is confirmed; however the cause is unknown.One 3 fr single lumen powerpicc provena was returned for evaluation.An initial visual observation showed the luer connector was detached from the extension tubing.Use residue was observed throughout the returned sample.The sample was flushed with a 12 ml syringe of water and was found to be patent to infusion.No leaks were observed when the sample was pressurized.Blood residue was expelled from the catheter sample when it was flushed.A microscopic observation revealed the break surface of the extension tubing of the purple lumen was uneven and rough and exhibited cracks/fissures and beach marks, which are indicative of material fatigue; however the root cause of the break is unknown at this time.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that picc split in half where the hub meets the catheter; patient was not harmed, but line had to be removed and patient was stuck again.

• Brand Name: DOT PROV SP 3F SL MAX
• 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: 7397756
• Report Number: 3006260740-2018-00597
• Device Sequence Number: 680070
• Product Code: LJS
• UDI-Device Identifier: 00801741134425
• UDI-Public: (01)00801741134425
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall,Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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 Catalogue Number: S9173108PD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 MO