MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE 22G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0029YN

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdxs0080 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that opened new safestep but no needle cover, safety mechanism by rn.A new device was opened.No other information was provided.

Event Description

It was reported that opened new safestep but no needle cover, safety mechanism by rn.A new device was opened.No other information was provided.

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 missing needle sheath was inconclusive due to the condition of the returned sample.The product returned for evaluation was one 22ga x 0.75¿ safestep safety infusion set with y-site.The sample was received with its original packaging label.The rest of the package was not returned for evaluation.The sample was received with the safety mechanism engaged, but appeared free of obvious usage residues.The luer dead end cap and needle sheath were not returned for evaluation.While the needle sheath was not returned with the sample, the opened state of the packaging and evidence of device manipulation prevented determination of the state of the device upon receipt by the complainant.Consequently this complaint is inconclusive at this time.Evaluation findings are in section h.11.

• Brand Name: SAFESTEP HUBER NEEDLE 22G X 0.75IN WITH Y-SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10764526
• MDR Text Key: 215342667
• Report Number: 3006260740-2020-20313
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066177
• UDI-Public: (01)00801741066177
• Combination Product (y/n): N
• PMA/PMN Number: K040527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: LH-0029YN
• Device Catalogue Number: LH-0029YN
• Device Lot Number: ASDXS0080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other