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

Device Problem Split (2537)

Patient Problem Venipuncture (2129)

Event Date 03/12/2018

Event Type  malfunction  

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 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.

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 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
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7397756
• MDR Text Key: 104566474
• Report Number: 3006260740-2018-00597
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741134425
• UDI-Public: (01)00801741134425
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S9173108PD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 20 MO