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Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Code Available (3191)
Event Date 09/25/2019
Event Type  malfunction  
Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
Event Description
It has been reported that one unspecified bd¿ syringe has been found experiencing leakage during use. The following has been provided by the initial reporter: material no. : unknown batch no. : unknown. It was reported that there was leaking out of the back of the syringe. Per email: i do have a report of an issue with the syringe that was infusing tpn on a nicu baby and it was leaking out of the back. It is very clear that it is coming out the back of the plunger: notified by rn that iv pump alarming occlusion frequently since beginning of shift and infant's blood sugar was 44 mg/dl. Picc dressing had been changed on the day shift. Cnp to bedside to assess picc line. No occlusion noted to external picc line or dressing, no signs of infiltration. No occlusion noted in iv tubing, no resolution with holding infant's arm straight. Picc lumen flushed sterilely at the hub and was patent. Decided to change out iv tubing. During attempt to re-prime fluid it was noted that the tpn syringe was defective and leaking at/around the plunger. This was left disconnected from the patient and second lumen tpn rate was increased to run total tpn rate. New iv fluids were ordered. Defective syringe bagged and left for nicu pharmacist to inspect as well. Date (b)(6) 2019 incident occurred when pt was (b)(6) days old yes harm ¿ bs of 44 recheck bs, fluids, and new tpn made/credited. The syringe i have had 52mls of tpn and all of the tubing connected.
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Type of DeviceSYRINGE
Manufacturer (Section D)
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
MDR Report Key9209127
MDR Text Key176050591
Report Number2243072-2019-02330
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/18/2019 Patient Sequence Number: 1