MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 20G 8CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number F120081

Device Problem Material Twisted/Bent (2981)

Patient Problem Pain (1994)

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, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recq1252 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that after placement, the midline had kinked internally and was causing pain.The device was subsequently removed.No patient harm 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 of a catheter kink is inconclusive due to poor sample condition.One 20 ga x 8 cm pflex catheter was returned for investigation.Use residue was observed throughout the sample.No apparent kinks in the catheter were observed.Manipulation of the sample revealed it to preferentially kink at the proximal end of the catheter.Based on the description of the reported event and condition of the returned sample, possible contributing factors include placement and securement technique.The catheter did not display any permanent kinking upon return but may have experienced kinking under clinical use; therefore, the complaint is inconclusive due to poor sample condition.A lot history review (lhr) of recq1252 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that after placement, the midline had kinked internally and was causing pain.The device was subsequently removed.No patient harm reported.

• Brand Name: DOT PG PRO 20G 8CM FULL
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7682007
• MDR Text Key: 114011670
• Report Number: 3006260740-2018-01704
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110573
• UDI-Public: (01)00801741110573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

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
• Device Operator: Health Professional
• Device Model Number: F120081
• Device Catalogue Number: F120081
• Device Lot Number: RECQ1252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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