MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET 20G X 0.75IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	0604190
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/06/2018
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 to the manufacturer for evaluation.A lot history review (lhr) of recr0715 showed seven other similar product complaint(s) from this lot number.The complaints for this lot number (recr0715) have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported that leakage was noticed eight times on the needle/extension set during administration of chemotherapy (2x carboplatinum), during infusion or dripping of nacl 0.9%, or injection of medication with syringe (like licitan).This report addresses the first event.
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 in the winged infusion set was inconclusive since the returned samples were same lot samples and were not the affected units.Thirty winged infusion sets were returned for investigation.One sample was received in open packaging, but appeared to be unused.The remaining samples were received in sealed packaging.Each infusion set was flushed with water and no occlusions were observed.Each infusion set was pressurized, but no leaks were observed.The syringe plunger was retracted while the infusion set was full of water and the needle tip was occluded, but no air entered the infusion set.Since the affected units were not returned for investigation and since no damage was identified on the returned same lot samples, the complaint was inconclusive.A lot history review (lhr) of recr0715 showed seven other similar product complaint(s) from this lot number.The complaints for this lot number (recr0715) have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported that leakage was noticed eight times on the needle/extension set during administration of chemotherapy (2x carboplatinum), during infusion or dripping of nacl 0.9%, or injection of medication with syringe (like licitan).This report addresses the first event.

• Brand Name: WINGED INFUSION SET 20G X 0.75IN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7838203
• Report Number: 3006260740-2018-02310
• Device Sequence Number: 19450095
• Product Code: FMI
• UDI-Device Identifier: 00801741065804
• UDI-Public: (01)00801741065804
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: 0604190
• Device Catalogue Number: 0604190
• Device Lot Number: RECR0715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1