MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER MIDLINE CATHETER, 4F SL; INTRAVASCULAR CATHETER

Model Number	CK000523
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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) of rebq1085 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales rep, the facility reported that the catheter came apart below the hub while inserted in the patient.The catheter was removed with no report of harm to the patient.
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 break in the extension leg was confirmed, but the exact cause of the damage was unknown.One purple midline connector and purple clamp labeled with 7ml/sec max were returned for investigation.Extension tubing was visible within the distal end of the connector.The distal end of the extension leg tubing was recessed within the connector.A microscopic examination of the extension tubing revealed a jagged and uneven surface.The characteristics observed on the extension leg indicate that the tubing tore.The break in the extension leg could be attributable to pulling, twisting, and manipulating the luer adaptor.A review of the device history record (dhr) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot.
Event or Problem Description
Per sales rep, the facility reported that the catheter came apart below the hub while inserted in the patient.The catheter was removed with no report of harm to the patient.

• Brand Name: POWER MIDLINE CATHETER, 4F SL
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6758900
• Report Number: 3006260740-2017-01192
• Device Sequence Number: 13689804
• Product Code: PND
• UDI-Device Identifier: 00801741101304
• UDI-Public: (01)00801741101304
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2017

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: CK000523
• Device Catalogue Number: CK000523B
• Device Lot Number: REBQ1085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1