MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYR 10ML SURESCRUB POSIFLUSH SALINE; SALINE, VASCULAR ACCESS FLUSH; PAD, ALCOHOL, DEVICE DISINFECTANT

Catalog Number	306559
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device type: ngt; lkb.Pma / 510(k)#: k161552 (syringe), k121655 (alcohol pad).Investigation summary: no sample was received.Investigation conclusion: this is the 2nd complaint for the lot# 8362820 for the same defect or symptom.Previous complaint (b)(4).There was no documentation of issues for the complaint of batch 8362820 during the production run.Root cause description: root cause can¿t be confirmed.
Event or Problem Description
It was reported that the plunger separated with a bd syr 10ml surescrub posiflush saline.The following information was provided by the initial reporter: (2 of 2).Material no: 306559, batch no: 8362820.It was reported that plunger separates from syringe.Per customer email: one syringe out of the box that did pop off pre-maturely.Used the whole box except for 2 syringes.Seems to think this was much better as with the other lot syringes, it was happening very frequently.

• Brand Name: BD SYR 10ML SURESCRUB POSIFLUSH SALINE
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH; PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8713741
• Report Number: 1911916-2019-00603
• Device Sequence Number: 11183840
• Product Code: NGT
• UDI-Device Identifier: 30382903065593
• UDI-Public: 30382903065593
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

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: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 306559
• Device Lot Number: 8362820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other