MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 20G X .0.75"; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recs3096 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that when attempting to attach the needleless connector to the end of the tubing, the tubing/connection was cracked.It is stated that no force was used to tighten the connection.Additional information received stated: "the patients skin was burned.".
Additional Manufacturer Narrative
Correction: the supplemental indicated where malfunction - product problem, additional details received on 12/21/2018 changed the mdr classification and adverse event report type to serious injury - adverse event.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 leak during infusion was inconclusive because the original implicated device was not returned and the sealed lot samples did not exhibit the described issue.The product returned for evaluation was two sealed 20ga huber plus infusion sets.No damage was seen on the devices within the trays and no damage was seen to the packaging.The samples were opened and thoroughly inspected for damage, and none was found.Functional testing using water and a 12ml syringe did not reveal a leak.Further functional testing included tightly attaching the luer hub to four different devices and vigorously infusing while also manipulating the interfacing features of the device.No leakage was seen during any of the infusion procedures.Final inspection following functional testing found no evidence of cracks or damage.Microscopic examination of the device likewise found no evidence of damage, defect, or deformity.As no device leakage was encountered during the evaluation, and no potential for cracks or leakage was observed, the complaint was unconfirmed.
Event or Problem Description
It was reported that when attempting to attach the needleless connector to the end of the tubing, the tubing/connection was cracked.It is stated that no force was used to tighten the connection.Additional information received stated: "the patient's skin was burned.".
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 leak during infusion was inconclusive because the original implicated device was not returned and the sealed lot samples did not exhibit the described issue.The product returned for evaluation was two sealed 20ga huber plus infusion sets.No damage was seen on the devices within the trays and no damage was seen to the packaging.The samples were opened and thoroughly inspected for damage, and none was found.Functional testing using water and a 12ml syringe did not reveal a leak.Further functional testing included tightly attaching the luer hub to four different devices and vigorously infusing while also manipulating the interfacing features of the device.No leakage was seen during any of the infusion procedures.Final inspection following functional testing found no evidence of cracks or damage.Microscopic examination of the device likewise found no evidence of damage, defect, or deformity.As no device leakage was encountered during the evaluation, and no potential for cracks or leakage was observed, the complaint was unconfirmed.
Event or Problem Description
It was reported that when attempting to attach the needleless connector to the end of the tubing, the tubing/connection was cracked.It is stated that no force was used to tighten the connection.Additional information received stated: "the patients skin was burned.".

• Brand Name: HUBER PLUS 20G X .0.75"
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8189493
• Report Number: 3006260740-2018-03644
• Device Sequence Number: 16650397
• Product Code: FPA
• UDI-Device Identifier: 00801741065620
• UDI-Public: (01)00801741065620
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K993848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 012034
• Device Lot Number: RECS3096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/05/2019; 02/05/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 02/12/2019; 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1