MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	LH-0030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2018
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, at this time, to the manufacturer for evaluation.A lot history review (lhr) of asats0210 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported nurse accessed adult patient port at home for ordered blood draw.Port accessed without problems, initial flush, patency check o.K.After drawing blood, nurse administered 2 (10 ml) normal saline (pre-filled) flushes per protocol.First flush without incident.When reaching end of second normal saline flush (flush content left was approximately 1 ml), nurse noticed a ¿single small bubble of liquid¿ appeared at the area where the extension tubing connects with the insertion handle.The remaining saline (1 ml) was administered.Next, a 5 ml (100 u/ml) heparin lock (pre-filled syringe) was administered (prior to de-accessing the needle).When injecting the heparin lock, upon reaching the final 1 ml mark on the syringe ¿ again, a ¿single small bubble of liquid¿ appeared at the area where the extension tubing meets the needle insertion handle.The heparin lock was completed by the nurse (i.E.The final 1 ml of heparin was administered into the port).
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 bubbles in the extension tubing was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 22ga x 1¿ safestep safety infusion set.The sample was received with the safety mechanism engaged and usage residues were evident throughout the sample.A needleless injection cap was attached to the luer adapter.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration; however, during aspiration, bubbles were noted in the extension tubing.During hydraulic pressurization, a leak was observed emanating from the needle housing.Microscopic inspection of the sample using an ultraviolet light revealed voids in the adhesive coverage within the housing.The leak appeared to be caused by a fluid path resulting from incomplete adhesive coverage within the needle housing.Such incomplete coverage appeared to be caused by void introduction/formation during device assembly.The device is a supplied component and the supplier has been notified of this event.A lot history review (lhr) of asats0210 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported nurse accessed adult patient port at home for ordered blood draw.Port accessed without problems, initial flush, patency check o.K.After drawing blood, nurse administered 2 (10 ml) normal saline (pre-filled) flushes per protocol.First flush without incident.When reaching end of second normal saline flush (flush content left was approximately 1 ml), nurse noticed a ¿single small bubble of liquid¿ appeared at the area where the extension tubing connects with the insertion handle.The remaining saline (1 ml) was administered.Next, a 5 ml (100 u/ml) heparin lock (pre-filled syringe) was administered (prior to de-accessing the needle).When injecting the heparin lock, upon reaching the final 1 ml mark on the syringe ¿ again, a ¿single small bubble of liquid¿ appeared at the area where the extension tubing meets the needle insertion handle.The heparin lock was completed by the nurse (i.E.The final 1 ml of heparin was administered into the port).

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7604002
• Report Number: 3006260740-2018-01405
• Device Sequence Number: 2194914
• Product Code: FPA
• UDI-Device Identifier: 00801741066184
• UDI-Public: (01)00801741066184
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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: LH-0030
• Device Catalogue Number: LH-0030
• Device Lot Number: ASATS0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1