MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV SP 4F DL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number S3274108PD

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebt1403 showed no other similar product complaint(s) from this lot number.Device has not been returned, at this time.

Event Description

It was reported that the picc catheter was placed in the (b)(6) femoral vein.The purple end came apart from the catheter about a week later.No patient injury was reported.

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 that the purple connector separated from the catheter was confirmed and additional information regarding this type of complaint is contained in the internal investigation.One dot prov sp 4f dl max was returned for investigation.Evidence of use was observed throughout the device.The catheter was attached to a statlock.Red colored residue was observed on the statlock.The purple connector and clamp were detached and received separate from the catheter.The catheter was cut at the 25 cm depth mark.The patient guide was returned and dated as may 14, 2018.The patient guide indicated base line right upper leg circumference of 26 cm.The catheter french size was listed as 4 and the catheter trim length was listed as 25 cm.The picc insertion site was the right femoral and 0 cm of external catheter was exposed from insertion site.The microscopic evaluation revealed what resembled beach marks in the cross section of the extension leg tubing.The surface of the extension leg within the purple connector was observed to be uneven.A tactile evaluation revealed nothing remarkable.A lot history review (lhr) of rebt1403 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the picc catheter was placed in the infant's femoral vein.The purple end came apart from the catheter about a week later.No patient injury was reported.

• Brand Name: DOT PROV SP 4F DL 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7602611
• MDR Text Key: 111667594
• Report Number: 3006260740-2018-01380
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741134326
• UDI-Public: (01)00801741134326
• 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,user f
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S3274108PD
• Device Lot Number: REBT1403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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