MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL ¿ SPIKE SET; INJECTOR

Catalog Number 515505-ZAT

Device Problems Break (1069); Fluid/Blood Leak (1250); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd phaseal ¿ spike set had a broken injector and the needle was exposed, medication leaked.No serious injury or medical intervention was reported.

Manufacturer Narrative

Correction: the medical device manufacturer for this product is atom, an eom.Medical device manufacturer: atom.

Event Description

It was reported that bd phaseal ¿ spike set had a broken injector and the needle was exposed, medication leaked.No serious injury or medical intervention was reported.

Event Description

It was reported that bd phaseal spike set had a broken injector and the needle was exposed, medication leaked.No serious injury or medical intervention was reported.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.

Manufacturer Narrative

Investigation summary: one sample unit was received for evaluation by our quality engineer team.Upon inspection of the sample, the grips of the safety sleeve were observed broken and out of place.As a lot number was unknown for this incident, a production history review could not be performed and additional retained samples could not be investigated.Needle exposure is a result of safety sleeve breakage.Safety sleeve breakage occurs when the injector is not properly disengaged.It is important to hold onto the white part of the injector when engaging/disengaging; do not touch the blue safety sleeve.If the grips of the safety sleeve are dislocated, the injector is activated and the needle is exposed.The injector must be removed by pulling straight back.If the injector is not removed by pulling straight back, the grips may become dislocated.If the injector has been forced while engaging, the grips may also become damaged.Investigation conclusion: the exposure of the needle is caused due to the breakage of the safety sleeve.The breakage occurs when the injector is not properly disengaged.It is important to hold onto the white part of the injector before engaging/disengaging.Do not touch the blue part.If the grips of the safety sleeve are remove from their place, the injector is activated causing needle exposure.The injector must be removed pulling it back, if it is removed without doing this the grips are removed from their place and needle exposure happens.If the injector has been forced while engaging, the grips can also get damaged.

Event Description

It was reported that bd phaseal ¿ spike set had a broken injector and the needle was exposed, medication leaked.No serious injury or medical intervention was reported.

• Brand Name: BD PHASEAL ¿ SPIKE SET
• Type of Device: INJECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7745298
• MDR Text Key: 116051732
• Report Number: 3003152976-2018-00335
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515505-ZAT
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other