MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SAFETYGLIDE SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Leak/Splash (1354); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6)."unknown manufacturer: 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 in and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or samples were received for evaluation.Since no samples displaying the reported condition were received a potential root cause could not be defined.Since no samples displaying the reported condition were received corrective actions are not necessary.

Event Description

It was reported that unspecified bd safetyglide syringes had the following problems: safety mechanism - failure (1).Needle clogged/blocked (3).Leakage (1).Needle and syringe separate / spin out (1).Needle stick (2).The following was reported by the initial reporter: "it was reported via survey response that the clinician experienced needlestick injury after patient use prior to safety mechanism activation (1), needlestick injury after patient use after safety mechanism activation (locked over needle) (1), needle clogged (1), unable to inject medications (1), needle detaches from syringe (1), unable to aspirate medications (1), needle dull/blunt (1), scale marking missing/illegible (1), needle pulled out of hub (1), leakage (1).Per customer's response opn (b)(6) 2021 ((b)(6) translation) md in principle they were facts of the past, years ago.None have happened recently.I don't have the batch number for catalog n.But i think it is not important.All the best dr.(b)(6).Additional information related to what leaked and from where states: "intravenous fluid" "i don't recall" additional information related to nsi prior to safety activation states: "the patient used it incorrectly." additional information related to nsi after safety activation states: "hardly anything.".

• Brand Name: UNSPECIFIED BD SAFETYGLIDE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11626948
• MDR Text Key: 260975582
• Report Number: 2243072-2021-00975
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention