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
Health Effect - Clinical Code	Pain (1994)
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 recq1252 showed no other similar product complaint(s) from this lot number.
Event or Problem 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.
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 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 or Problem 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
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7682007
• Report Number: 3006260740-2018-01704
• Device Sequence Number: 16472878
• Product Code: FOZ
• UDI-Device Identifier: 00801741110573
• UDI-Public: (01)00801741110573
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1