MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/30/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.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 "at approximately 1320 patient's line was flushed and positive blood return was present.Approximately ten minutes later, family called and blood had leaked through the distal end of the tubing attached to the needle just before the clave.The rn clamped the tube and flushed ns through and found a hole/crack near the needless connector.The rn then de-accessed and re-accessed the port." originally accessed 10/24/21 @ 1415, so 6 days in total no other treatment needed aside from new needle was running normal saline at 3ml/hr when leaking discovered no infiltration or extravasation noted.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was confirmed and the cause is currently under investigation.The product returned for evaluation was one 20ga x 0.75" powerloc max saefty infusion set.The returned product sample was evaluated and the following observations were made: the fracture surfaces of the damage contained striation-like patterns, tear patterns and buckling which were indicative of flexural fatigue based material failure.While repetitive mechanical stresses such as twisting and kinking may have contributed to the observed event, it appeared that additional unidentified factors also contributed.The device is a supplied component and the supplier has been notified of this event.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported "at approximately 1320 patient's line was flushed and positive blood return was present.Approximately ten minutes later, family called and blood had leaked through the distal end of the tubing attached to the needle just before the clave.The rn clamped the tube and flushed ns through and found a hole/crack near the needless connector.The rn then de-accessed and re-accessed the port." originally accessed (b)(6) 21 @ 1415, so 6 days in total.No other treatment needed aside from new needle.Was running normal saline at 3ml/hr when leaking discovered.No infiltration or extravasation noted.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12910447
• MDR Text Key: 281589576
• Report Number: 3006260740-2021-05086
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047466
• UDI-Public: (01)00801741047466
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0142075
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• 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 Outcome(s): Other
• Patient Age: 11 MO